Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

SJG-136 in Treating Patients With Advanced Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over NCI MSKCC-04076 6818, NCI-6818, NCT00103220

Objectives

Primary

1. Determine the recommended phase II dose of SJG-136 in patients with advanced solid tumors.
2. Determine the toxic effects of this drug in these patients.
3. Determine the pharmacokinetics of this drug in these patients.

Secondary

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

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

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

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• At least 4 weeks since prior radiotherapy
• No prior radiotherapy to ≥ 25% of hematopoietic bone marrow

Surgery

• Not specified

Other

• 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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

  OR

• Karnofsky 60-100%

Life expectancy

• More than 3 months

Hematopoietic

• WBC ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

Hepatic

• Bilirubin ≤ 1.0 mg/dL
• AST and ALT ≤ 2.5 times upper limit of normal

Renal

• Creatinine < 1.4 mg/dL

Cardiovascular

• No congestive heart failure
• No recent myocardial infarction
• No unstable angina
• No uncontrolled hypertension

Other

• 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

Expected Enrollment

A total of 3-36 patients will be accrued for this study.

Outline

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

Patients receive SJG-136 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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Naiyer Rizvi, MD, Protocol chair		Ph: 212-639-3204; 800-525-2225

Registry Information
Official Title		A Phase I Study with SJG-136 (NSC#694501) in Patients with an Advanced Solid Tumor
Trial Start Date		2004-12-16
Registered in ClinicalTrials.gov		NCT00103220
Date Submitted to PDQ		2004-12-01
Information Last Verified		2007-03-08
NCI Grant/Contract Number		CA15083, CA69856