SJG-136 in Treating Patients With Advanced Solid Tumors

National Cancer Institute (NCI)

Status and phase: Completed; Phase 1

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Drug: SJG-136

Study type: Interventional

Funder types: NIH

Identifiers

NCT00103220

04-076 (Other Identifier)

CDR0000409581

MSKCC-04076

U01CA069856 (U.S. NIH Grant/Contract)

NCI-6818

NCI-2012-01462 (Registry Identifier)

6818 (Other Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

36 participants in 1 patient group

Treatment (SJG-136)

Experimental group

Description:

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.

Treatment:

Drug: SJG-136