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A Phase I Study With SJG-136 (NSC #694501) in Patients With an Advanced Solid Tumor

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Study With SJG-136 (NSC #694501) in Patients With an Advanced Solid Tumor


I. To determine the toxicities, pharmacokinetic profile and the recommended phase 2 dose of
SJG-136 in patients with an advanced solid tumor.


I. To determine preliminary efficacy data and evaluation of correlative markers of DNA
damage and apoptosis in peripheral blood lymphocytes.

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

Patients receive SJG-136 intravenously (IV) over 20 minutes on days 1, 8, and 15. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts
of 3-6 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.

Inclusion Criteria:

- Histologically confirmed solid tumor

- Advanced disease, defined as metastatic or unresectable disease

- Measurable indicator lesions

- Standard curative or palliative measures do not exist or are no longer effective

- Previously treated CNS metastases allowed provided patient has completed local
therapy AND corticosteroids have been discontinued for at least 4 weeks

- No known leptomeningeal metastases

- Performance status - ECOG 0-2

- Performance status - Karnofsky 60-100%

- More than 3 months

- WBC ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin ≤ 1.0 mg/dL

- AST and ALT ≤ 2.5 times upper limit of normal

- Creatinine < 1.4 mg/dL

- No congestive heart failure

- No recent myocardial infarction

- No unstable angina

- No uncontrolled hypertension

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active infection

- No history of allergic reaction attributed to compounds of similar chemical or
biological composition to study drug

- No other significant medical history, unstable medical condition, or unstable
systemic disease that would preclude study participation

- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas and
8 weeks for UCN-01)

- At least 4 weeks since prior radiotherapy

- No prior radiotherapy to ≥ 25% of hematopoietic bone marrow

- Recovered from all prior therapy

- At least 4 weeks since prior investigational anticancer drugs

- No other concurrent investigational agents

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended phase 2 dose of SJG-136

Outcome Description:

Defined as when ≤1 out of 6 patients achieve dose-limiting toxicity (DLT) at highest dose level below the maximally administered dose.

Outcome Time Frame:

Day 28

Safety Issue:


Principal Investigator

Naiyer Rizvi

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 2004

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021