SJG-136 in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial is studying the side effects and best dose of SJG-136 in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as SJG-136, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

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