SJG-136 in Treating Patients With Advanced Solid Tumors

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

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.

Study Overview

• Status: Completed
• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Intervention / Treatment: Drug: SJG-136

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (SJG-136); 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.	Drug: SJG-136; Given IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recommended phase 2 dose of SJG-136	Defined as when ≤1 out of 6 patients achieve dose-limiting toxicity (DLT) at highest dose level below the maximally administered dose.	Day 28

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Naiyer Rizvi, Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): February 1, 2007

Study Registration Dates

• First Submitted: February 7, 2005
• First Submitted That Met QC Criteria: February 7, 2005
• First Posted (Estimate): February 8, 2005

Study Record Updates

• Last Update Posted (Estimate): December 11, 2013
• Last Update Submitted That Met QC Criteria: December 10, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: NCI-2012-01462 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); U01CA069856 (U.S. NIH Grant/Contract); MSKCC-04076; CDR0000409581; NCI-6818; 04-076 (Memorial Sloan-Kettering Cancer Center); 6818 (CTEP)