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Phase I/II Study of High-Dose Calcitriol Plus Temodar for Patients With Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT00301067
Recruitment Status : Completed
First Posted : March 10, 2006
Results First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Melanoma
Interventions Dietary Supplement: Calcitriol
Drug: Temozolomide
Enrollment 20
Recruitment Details The study opened for accrual on January 13, 2005 with an accrual goal of between 19-28 patients. Accrual was suspended on March 22 2007, reopening May 7 2007, suspended again January 4, 2008, reopening February 14 2008 both times for toxicity evaluations. The study closed permanently on October 28, 2011 with 20 patients enrolled on the study.
Pre-assignment Details  
Arm/Group Title Cohort 1 - Temozolomide and Calcitriol Cohort 2 - Temozolomide and Calcitriol Cohort 3 - Temozolomide and Calcitriol Expansion - Temozolomide and Calcitriol
Hide Arm/Group Description

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.2 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.3 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Period Title: Completed DLT Period/1st Cycle
Started 4 3 3 10 [1]
Completed 3 3 3 9
Not Completed 1 0 0 1
Reason Not Completed
Progressive Disease             1             0             0             1
[1]
Patients did not participate in the DLT portion of the trial, they completed 1st cycle of treatment.
Period Title: Reached 1st Response/2 Cycles
Started 3 3 3 9
Completed 1 2 2 7
Not Completed 2 1 1 2
Reason Not Completed
Progressive Disease             2             1             1             2
Period Title: Completed 4 Cycles of Treatment
Started 1 2 2 7
Completed 0 1 0 2
Not Completed 1 1 2 5
Reason Not Completed
Progressive disease             1             1             2             5
Period Title: Completed 12 Cycles of Treatment
Started 0 1 0 2
Completed 0 0 0 0
Not Completed 0 1 0 2
Reason Not Completed
Progressive Disease             0             1             0             1
Adverse Event             0             0             0             1
Period Title: Follow up Until Death
Started [1] 4 3 3 3
Completed 3 3 3 2
Not Completed 1 0 0 1
Reason Not Completed
Alive at last data cut point             1             0             0             1
[1]
All patients that receive treatment on study go into the follow up period for study.
Arm/Group Title Temozolomide and Calcitriol (Cohort 1-3+Expansion)
Hide Arm/Group Description

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.2, 0.3, or 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  55.0%
>=65 years
9
  45.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
5
  25.0%
Male
15
  75.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
20
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
20
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
 100.0%
1.Primary Outcome
Title Number and Frequency of Dose Limiting Toxicities (DLTs) With High-dose Calcitriol in Combination With Temozolomide
Hide Description

Determine number and frequency of dose limiting toxicities (DLT) of high-dose calcitriol when administered with temozolomide in patients with metastatic melanoma for up to 12 cycles of therapy, where 1 cycle equals 28 days.

3 patients per dose cohort will be entered into the trial at doses of 0.2, 0.3, and 0.5 mcg/kg of calcitriol administered orally. If 1 patient experiences dose limiting toxicity (DLT) at any dose, that dose cohort will be expanded to a maximum of 6 patients. If 1 additional patient experiences DLT at that dose stratum, further dose escalation will cease and the dose cohort immediately preceding the dose cohort where the 2 experiences of DLT occurred will be considered the MTD. If no additional patients experience DLT, dose escalation to the next higher dose stratum will take place.

DLT is defined as National Cancer Institute Common Toxicity Criteria, version 3.0 grade 3 toxicity determined to be related to calcitriol.

Time Frame From start of treatment, up to 12 cycles where 1 cycle equals 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
1 patient enrolled in cohort 1 was not evaluable for this outcome measure as the patient only received 8 days of treatment. Patients enrolled in the expansion cohort were not evaluable for this outcome measure.
Arm/Group Title Cohort 1 - Temozolomide and Calcitriol Cohort 2 - Temozolomide and Calcitriol Cohort 3 - Temozolomide and Calcitriol
Hide Arm/Group Description:

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.2 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.3 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Overall Number of Participants Analyzed 3 3 3
Measure Type: Number
Unit of Measure: DLT
0 0 0
2.Primary Outcome
Title Number of Patients With Toxicity
Hide Description

Toxicity will be assessed for each patient on a seven-day on/seven-day off temozolomide in combination with high-dose calcitriol for every 2 weeks for up to 12 cycles where 1 cycle equals 28 days. Toxicity will be assessed during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0) and defined by any toxicity determined to be at least possibly related to either study drug (temozolomide or calcitriol).

In general adverse events (AEs) will be graded according to the following:

Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE

Grade 3 and grade 4 toxicities where relatedness to either study drug could not be ruled out were collected and recorded only.

Time Frame From the start of treatment and every 2 weeks for a maximum of 12 cycles, and 30 days post last treatment, where 1 cycle equals 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients that receive one dose of study drug were evaluable for this outcome measure.
Arm/Group Title Cohort 1 - Temozolomide and Calcitriol Cohort 2 - Temozolomide and Calcitriol Cohort 3 - Temozolomide and Calcitriol Expansion - Temozolomide and Calcitriol
Hide Arm/Group Description:

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.2 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.3 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Overall Number of Participants Analyzed 4 3 3 9
Measure Type: Number
Unit of Measure: participants
Thrombocytopenia 1 0 0 1
Vascular 1 0 0 1
Nausea 0 0 1 0
Vomiting 0 0 1 0
Leukopenia 0 0 1 1
Fatigue 0 0 0 1
Anemia 0 0 0 2
Lymphopenia 0 0 0 2
Hemorrhage 0 0 0 1
Rash 0 0 0 1
Anorexia 0 0 0 1
3.Secondary Outcome
Title Tumor Response
Hide Description

Determine best tumor response during treatment. Response and progression was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). The same method of assessment and the same technique should be used to characterize each identified and reported lesion at baseline and during follow-up.

Complete Response (CR): Disappearance of all target lesions

Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD

Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Time Frame At baseline and every 8 weeks during treatment for a maximum of 12 cycles where one cycle equals 28 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Cohort results for this outcome measure are combined as the objective was to determine the tumor response of patients with this drug combination (dose was irrelevant)
Arm/Group Title Temozolomide and Calcitriol (Cohort 1-3+Expansion)
Hide Arm/Group Description:

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.2, 0.3, or 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
Partial Response
2
  10.0%
Stable Disease
1
   5.0%
Progressive Disease
17
  85.0%
4.Secondary Outcome
Title The Relationship Between Vitamin D-receptor Gene Polymorphisms and Tumor Response
Hide Description Investigate the relationship between vitamin D-receptor (VDR) gene polymorphisms in Taq1 and Fok1 (analyzed from baseline blood sample) and tumor response. VDR gene analysis was completed using PCR-RFLP based assays.
Time Frame Baseline and at disease progression or when patient goes off study up to a maximum of 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Cohort results for this outcome measure are combined as the objective was to investigate relationship of VDR gene polymorphisms present and tumor response of patients with this drug combination (dose was irrelevant) Data was not collected or analyzed for this outcome measure.
Arm/Group Title Temozolomide and Calcitriol (Cohort 1-3+Expansion)
Hide Arm/Group Description:

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.2, 0.3, or 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Post-Hoc Outcome
Title Overall Response Rate
Hide Description

Overall Response Rate (ORR) is defined as percentage of patients who's best response to treatment is complete response plus those with partial response.

Complete Response (CR): Disappearance of all target lesions.

Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Time Frame From the start of treatment, every 2 cycles where 1 cycle equals 28 days, for a maximum of 12 cycles
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Cohort results for this outcome measure are combined as the objective was to determine the ORR of patients with this drug combination (dose was irrelevant)
Arm/Group Title Temozolomide and Calcitriol (Cohort 1-3+Expansion)
Hide Arm/Group Description:

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.2, 0.3, or 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
2
  10.0%
6.Post-Hoc Outcome
Title Time to Progression
Hide Description Time to progression (TTP) is measured from the start of treatment until the time of first documentation of disease progression.
Time Frame From the start of treatment, until progressive disease, up to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Cohort results for this outcome measure are combined as the objective was to determine the TTP for patients with this drug combination (dose was irrelevant)
Arm/Group Title Temozolomide and Calcitriol (Cohort 1-3+Expansion)
Hide Arm/Group Description:

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.2, 0.3, or 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Overall Number of Participants Analyzed 20
Median (Inter-Quartile Range)
Unit of Measure: Months
1.81
(1.15 to 1.99)
7.Post-Hoc Outcome
Title Overall Survival
Hide Description Overall Survival (OS) will be measured from first day of treatment until death of any cause. Patients still alive at the last data cut off point will be censored.
Time Frame From the first day of treatment until death from any cause, up to a maximum of 6 and half years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Cohort results for this outcome measure are combined as the objective was to determine the OS of patients with this drug combination (dose was irrelevant)
Arm/Group Title Temozolomide and Calcitriol (Cohort 1-3+Expansion)
Hide Arm/Group Description:

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.2, 0.3, or 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Overall Number of Participants Analyzed 20
Median (Inter-Quartile Range)
Unit of Measure: Months
5.5
(2.7 to 12.3)
8.Post-Hoc Outcome
Title Overall Survival (OS) Stratified by Vitamin D-Receptor (VDR) Gene Polymorphisms
Hide Description Investigate the relationship between vitamin D-receptor (VDR) gene polymorphisms in Taq1 and Fok1 (analyzed from baseline blood sample) and Overall Survival (OS). VDR gene analysis was completed using PCR-RFLP based assays.
Time Frame at baseline and until death from any cause up to 6 and half years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Cohort results for this outcome measure are combined as the objective was to determine the relationship between VDR gene polymorphisms and OS for patients with this drug combination (dose was irrelevant)
Arm/Group Title Temozolomide and Calcitriol (Cohort 1-3+Expansion)
Hide Arm/Group Description:

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.2, 0.3, or 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Overall Number of Participants Analyzed 17
Median (Inter-Quartile Range)
Unit of Measure: Months
VDR genotype (tt+/-ff) Number Analyzed 6 participants
3.8
(2.0 to 5.7)
non tt+/-ff VDR genotype Number Analyzed 11 participants
7.4
(3.0 to 12.3)
Time Frame Adverse events for the study were collected over a 6 year and 3 month period. For each patient adverse events were collected for a maximum of 12 cycles where 1 cycle equals 28 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1 - Temozolomide and Calcitriol Cohort 2 - Temozolomide and Calcitriol Cohort 3 - Temozolomide and Calcitriol Expansion - Temozolomide and Calcitriol
Hide Arm/Group Description

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.2 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.3 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.

Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

All-Cause Mortality
Cohort 1 - Temozolomide and Calcitriol Cohort 2 - Temozolomide and Calcitriol Cohort 3 - Temozolomide and Calcitriol Expansion - Temozolomide and Calcitriol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/4 (75.00%)      3/3 (100.00%)      3/3 (100.00%)      9/10 (90.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1 - Temozolomide and Calcitriol Cohort 2 - Temozolomide and Calcitriol Cohort 3 - Temozolomide and Calcitriol Expansion - Temozolomide and Calcitriol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/4 (50.00%)      1/3 (33.33%)      2/3 (66.67%)      4/10 (40.00%)    
Blood and lymphatic system disorders         
Thrombocytopenia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Gastrointestinal disorders         
Nausea and vomiting  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Metabolism and nutrition disorders         
Hyperglycemia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Rapidly declining performance status  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Death related to disease  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Nervous system disorders         
Confusion  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0
Slurred speech and drooling  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders         
Pneumonia  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0
Pulmonary embolus  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Skin and subcutaneous tissue disorders         
Rash  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 - Temozolomide and Calcitriol Cohort 2 - Temozolomide and Calcitriol Cohort 3 - Temozolomide and Calcitriol Expansion - Temozolomide and Calcitriol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      10/10 (100.00%)    
Blood and lymphatic system disorders         
Anemia (Hemoglobin decrease)  1  2/4 (50.00%)  2/3 (66.67%)  2/3 (66.67%)  6/10 (60.00%) 
Neutrophils decreased  1  0/4 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/10 (10.00%) 
Leukocytes (white blood count)  1  0/4 (0.00%)  0/3 (0.00%)  2/3 (66.67%)  3/10 (30.00%) 
Lymphopenia  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/10 (20.00%) 
Platelets decreased (thrombocytopenia)  1  2/4 (50.00%)  0/3 (0.00%)  1/3 (33.33%)  2/10 (20.00%) 
Limb edema  1  0/4 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/10 (10.00%) 
Edema in head and neck  1  0/4 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/10 (0.00%) 
Cardiac disorders         
Hypotension  1  0/4 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/10 (0.00%) 
Tachycardia  1  0/4 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/10 (0.00%) 
Eye disorders         
Vision changes  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/10 (10.00%) 
Gastrointestinal disorders         
Anorexia  1  0/4 (0.00%)  2/3 (66.67%)  2/3 (66.67%)  5/10 (50.00%) 
Constipation  1  2/4 (50.00%)  2/3 (66.67%)  1/3 (33.33%)  5/10 (50.00%) 
Dehydration  1  0/4 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/10 (10.00%) 
Diarrhea  1  0/4 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  1/10 (10.00%) 
Nausea  1  4/4 (100.00%)  2/3 (66.67%)  1/3 (33.33%)  9/10 (90.00%) 
Vomiting  1  2/4 (50.00%)  1/3 (33.33%)  1/3 (33.33%)  9/10 (90.00%) 
Blood in stool  1  0/4 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/10 (0.00%) 
Hemorrhage CNS  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/10 (10.00%) 
Abdominal pain - NOS  1  0/4 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/10 (0.00%) 
General disorders         
Fatigue  1  0/4 (0.00%)  2/3 (66.67%)  2/3 (66.67%)  6/10 (60.00%) 
Fever  1  0/4 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/10 (10.00%) 
Sweating  1  1/4 (25.00%)  0/3 (0.00%)  1/3 (33.33%)  0/10 (0.00%) 
Weight loss  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  5/10 (50.00%) 
Weight gain  1  0/4 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/10 (0.00%) 
Pain not otherwise specified  1  1/4 (25.00%)  2/3 (66.67%)  0/3 (0.00%)  1/10 (10.00%) 
Infections and infestations         
Urinary tract infection NOS  1  0/4 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  2/10 (20.00%) 
Oral infection  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/10 (20.00%) 
Skin infection  1  1/4 (25.00%)  0/3 (0.00%)  0/3 (0.00%)  0/10 (0.00%) 
Conjunctivitis  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/10 (10.00%) 
Metabolism and nutrition disorders         
Albumin, serum-low  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/10 (20.00%) 
Alkaline phosphatase  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/10 (10.00%) 
Transaminase  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  3/10 (30.00%) 
Bicarbonate - low  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/10 (10.00%) 
Bilirubin, serum high  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/10 (20.00%) 
Calcium, serum low  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/10 (10.00%) 
Creatinine - high  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/10 (10.00%) 
Glucose, serum high  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/10 (20.00%) 
Lactic acid dehydrogenase (LDH) increase  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/10 (20.00%) 
Sodium, serum low  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/10 (10.00%) 
Chest pain  1  0/4 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/10 (0.00%) 
Joint pain  1  1/4 (25.00%)  0/3 (0.00%)  0/3 (0.00%)  1/10 (10.00%) 
Neck pain  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/10 (10.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Tumor pain  1  0/4 (0.00%)  0/3 (0.00%)  2/3 (66.67%)  1/10 (10.00%) 
Nervous system disorders         
Confusion  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/10 (20.00%) 
Memory impairment  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/10 (10.00%) 
Motor Neuropathy  1  1/4 (25.00%)  0/3 (0.00%)  0/3 (0.00%)  2/10 (20.00%) 
Motor Neuropathy - Foot drop  1  1/4 (25.00%)  0/3 (0.00%)  0/3 (0.00%)  0/10 (0.00%) 
Lightheadedness  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/10 (10.00%) 
Cerebral vascular accident (CVA)  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/10 (10.00%) 
Headache  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/10 (10.00%) 
Psychiatric disorders         
Mood alteration - Anxiety  1  0/4 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  1/10 (10.00%) 
Mood alteration - Depression  1  0/4 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  2/10 (20.00%) 
Reproductive system and breast disorders         
Menstrual cramps  1  0/4 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/4 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders         
Hyperpigmentation  1  0/4 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/10 (0.00%) 
Rash/desquamation  1  0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/10 (10.00%) 
Vascular disorders         
Thrombosis  1  1/4 (25.00%)  0/3 (0.00%)  1/3 (33.33%)  1/10 (10.00%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Clinical Trials Office
Organization: Northwestern University
Phone: 312-695-1301
Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00301067     History of Changes
Other Study ID Numbers: NU 05M1
P30CA060553 ( U.S. NIH Grant/Contract )
NU-05M1
NU-0310-093
SPRI-NU-05M1
First Submitted: March 8, 2006
First Posted: March 10, 2006
Results First Submitted: October 22, 2018
Results First Posted: December 28, 2018
Last Update Posted: December 28, 2018