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Trial record 1 of 1 for:    NCT01005472
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Temozolomide and Sunitinib Malate in Treating Patients With Stage III or Stage IV Malignant Melanoma

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ClinicalTrials.gov Identifier: NCT01005472
Recruitment Status : Completed
First Posted : November 1, 2009
Last Update Posted : August 3, 2020
Sponsor:
Collaborators:
Pfizer
Schering-Plough
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE October 30, 2009
First Posted Date  ICMJE November 1, 2009
Last Update Posted Date August 3, 2020
Actual Study Start Date  ICMJE December 1, 2008
Actual Primary Completion Date January 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
  • Maximum tolerated dose of sunitinib malate when administered concurrently with temozolomide (Phase I) [ Time Frame: 6 weeks ]
  • Overall safety [ Time Frame: 5 years ]
  • Response rate as assessed by modified RECIST criteria (phase II) [ Time Frame: 5 years ]
    Phase II was never conducted due to toxicity in phase I.
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2009)
  • Maximum tolerated dose of sunitinib malate when administered concurrently with temozolomide (Phase I)
  • Overall safety (Phase I)
  • Response rate as assessed by modified RECIST criteria (phase II)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2013)
  • Response rate as assessed by modified RECIST criteria (Phase I) [ Time Frame: 6 weeks ]
  • Progression-free survival [ Time Frame: 5 years ]
  • Overall survival [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2009)
  • Response rate as assessed by modified RECIST criteria (Phase I)
  • Safety and tolerability (Phase II)
  • Progression-free survival
  • Overall survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Temozolomide and Sunitinib Malate in Treating Patients With Stage III or Stage IV Malignant Melanoma
Official Title  ICMJE A Phase I/II Study of Daily Oral Dosing With Temozolomide and Sunitinib Malate for 6 Weeks of an 8-Week Cycle in Patients With Metastatic and Unresectable Locally-Advanced Malignant Melanoma
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving temozolomide together with sunitinib malate may kill more tumor cells.

Phase II was never conducted due to toxicity in phase I.

PURPOSE: This phase I/II trial is studying the side effects and best dose of sunitinib malate when given together with temozolomide and to see how well they work in treating patients with stage III or stage IV malignant melanoma.

Detailed Description

OBJECTIVES:

Primary

  • Assess the maximum tolerated dose of sunitinib malate when administered concurrently with temozolomide in patients with stage IIIC or IV malignant melanoma. (Phase I)
  • Assess the overall safety of this regimen in these patients. (Phase I)
  • Determine the response rate in patients treated with this regimen. (Phase II) Phase II was never conducted due to toxicity in phase I.

Secondary

  • Determine the response rate in patients treated with this regimen. (Phase I)
  • Determine the safety and tolerability of this regimen in these patients. (Phase II)
  • Determine the progression-free survival of patients treated with this regimen.
  • Determine the overall survival of patients treated with this regimen.

OUTLINE: This is a phase I, dose-escalation study of sunitinib malate followed by a phase II study.

Patients receive oral sunitinib malate once daily and oral temozolomide once daily on days 1-42. Treatment repeats every 56 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up very 6 months for up to 5 years.

Phase II was never conducted due to toxicity in phase I.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Melanoma
Intervention  ICMJE
  • Drug: sunitinib malate
  • Drug: temozolomide
Study Arms  ICMJE Experimental: sunitinib malate, temozolomide
Interventions:
  • Drug: sunitinib malate
  • Drug: temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2018)
16
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2009)
48
Actual Study Completion Date  ICMJE January 17, 2018
Actual Primary Completion Date January 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed Stage IIIC unresectable cutaneous or mucosal melanoma with measureable disease or stage IV cutaneous, mucosal or ocular melanoma with measureable disease.
  • ECOG performance status of 0-2
  • age greater than or equal to 18 years
  • ANC ≥ 1,500/µL
  • Platelet count ≥ 100,000/µL
  • Hemoglobin ≥ 10.0 g/dL
  • Creatinine ≤ 2 times upper limit of normal (ULN)
  • Total bilirubin ≤ 2 times ULN
  • LDH ≤ 5 times ULN
  • AST or ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver metastasis is present)
  • LVEF ≥ 50% on screening ECHO
  • women of childbearing potential must have a negative urine or serum pregnancy test upto 28 days prior to commencement of dosing.
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
  • Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
  • before study entry , written informed consent must be obtained. Written informed consent must be obtained from patient prior to performing any study related procedures.

Exclusion Criteria

  • pregnant or nursing
  • any following within the past 12 months:
  • Myocardial infarction
  • Severe and/or unstable angina
  • Coronary and/or peripheral artery bypass graft
  • Symptomatic congestive heart failure
  • Cerebrovascular accident or transient ischemic attack
  • Pulmonary embolism
  • ongoing cardiac dysrhythmias ≥ grade 2, according to NCI CTCAE v3.0
  • prolonged QTc interval on baseline EKG
  • uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg despite optimal medical therapy)
  • pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
  • any known clinically uncontrolled infectious disease, including HIV positivity or AIDS-related illness
  • severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results, and, in the judgment of the investigator, would make the patient inappropriate for study entry
  • prior chemotherapy for melanoma, except for chemotherapy given during isolated limb perfusion for stage IIIC disease
  • Prior adjuvant immunotherapy and/or immunotherapy for metastatic disease allowed
  • prior major surgery, radiotherapy, or immunotherapy within 4 weeks of starting therapy
  • treatment with potent CYP3A4 inhibitors 7 days before study dosing
  • treatment with potent CYP3A4 inducers 12 days before study dosing
  • concurrent treatment on another clinical trial (Concurrent participation on supportive care trials or non-treatment trials (e.g., quality-of-life trials) allowed).
  • concurrent chemotherapy, immunotherapy, biological therapy, or investigational drugs
  • concurrent drugs with dysrhythmic potential, including any of the following:
  • Terfenadine
  • Quinidine
  • Procainamide
  • Disopyramide
  • Sotalol
  • Probucol
  • Bepridil
  • Haloperidol
  • Risperidone
  • Indapamide
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01005472
Other Study ID Numbers  ICMJE CDR0000634373
UCLA-0711052
SPRI-P05513
PFIZER-GA6181FZ
10-001406 ( Other Identifier: UCLA IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonsson Comprehensive Cancer Center
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE
  • Pfizer
  • Schering-Plough
Investigators  ICMJE
Principal Investigator: Bartosz Chmielowski, MD University of California, Los Angeles
PRS Account Jonsson Comprehensive Cancer Center
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP