SJG-136 in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed By Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00121290
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : February 24, 2014
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase I trial studies the side effects and best dose of SJG-136 in treating patients with solid tumors that are metastatic or cannot be removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: SJG-136 Other: laboratory biomarker analysis Other: pharmacological study Phase 1

Detailed Description:


I. Determine the maximum tolerated dose and recommended phase II dose of SJG-136 in patients with metastatic or unresectable solid tumors.

II. Determine the safety and dose-limiting toxic effects of this drug in these patients.

III. Determine, preliminarily, the efficacy of this drug in these patients.


I. Determine the pharmacokinetic parameters of this drug and its metabolites in these patients.

II. Correlate pharmacokinetic parameters with clinical effects of this drug in these patients.

OUTLINE: This is an open-label, dose-escalation study.

Patients receive SJG-136 intravenously (IV) over 20 minutes once daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-6 patients receive escalating doses of SJG-136 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.

After completion of study treatment, patients are followed up for 30 days.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study of Daily x 3 Intravenous SJG-136 in Patients With Advanced Solid Tumors
Study Start Date : February 2005
Actual Primary Completion Date : April 2008

Arm Intervention/treatment
Experimental: Treatment (SJG-136)
Patients receive SJG-136 IV over 20 minutes once daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: SJG-136
Given IV

Other: laboratory biomarker analysis
Correlative studies

Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Primary Outcome Measures :
  1. MTD defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Bivariate response variable (tumor response) evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have histologically confirmed solid tumor malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
  • Prior chemotherapy or immunotherapy allowed
  • Time interval must be at least 4 weeks since prior chemotherapy or immunotherapy, 6 weeks if the last regimen included BCNU or mitomycin C
  • Radiation therapy to < 25% of hematopoietic bone marrow is allowed
  • ECOG performance status =<2 (Karnofsky >= 60%)
  • Life expectancy of greater than three months
  • Recovered from prior therapy
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
  • Ability to understand and the willingness to sign a written informed consent document
  • WBC >= 3,000/mm^3
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Bilirubin normal
  • AST and ALT =< 2.5 times upper limit of normal
  • Creatinine =< 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
  • No unstable angina pectoris

Exclusion Criteria:

  • Patients receiving any other investigational agents
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study
  • Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SJG-136, breastfeeding should be discontinued if the mother is treated with SJG-136
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to SJG-136
  • HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with SJG-136
  • With the exception of alopecia (and other situations in which the organ dysfunction or symptoms are considered clinically insignificant or irrelevant to this study), patients may not have baseline organ dysfunction or symptoms that qualify as Grade 2 or greater by CTC AE v. 3.0
  • No other chemotherapy, immunotherapy, radiation therapy, surgery for cancer (including resection of any metastases), specific antitumor therapy, or experimental medications will be permitted while the patients are participating in this study
  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Palliative radiation therapy is not allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00121290

United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Igor Puzanov Vanderbilt-Ingram Cancer Center

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00121290     History of Changes
Other Study ID Numbers: NCI-2009-00085
NCI-2009-00085 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PHI 0453 ( Other Identifier: Vanderbilt-Ingram Cancer Center )
6816 ( Other Identifier: CTEP )
P30CA068485 ( U.S. NIH Grant/Contract )
U01CA099177 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: February 24, 2014
Last Verified: April 2013