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

Alternate Title

SJG-136 in Treating Patients With Metastatic or Unresectable Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over NCI VICC-PHI-0453 6816, NCT00121290, VICCPHI0453

Objectives

Primary

1. Determine the maximum tolerated dose and recommended phase II dose of SJG-136 in patients with metastatic or unresectable solid tumors.
2. Determine the safety and dose-limiting toxic effects of this drug in these patients.
3. Determine, preliminarily, the efficacy of this drug in these patients.

Secondary

1. Determine the pharmacokinetic parameters of this drug and its metabolites in these patients.
2. Correlate pharmacokinetic parameters with clinical effects of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed solid tumor
  • Metastatic or unresectable disease



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

Prior/Concurrent Therapy:

Biologic therapy

• At least 4 weeks since prior immunotherapy
• No concurrent anticancer immunotherapy

Chemotherapy

• At least 4 weeks since prior chemotherapy (6 weeks for carmustine or mitomycin)
• No other concurrent anticancer chemotherapy

Endocrine therapy

• No concurrent anticancer hormonal therapy

Radiotherapy

• No prior radiotherapy to ≥ 25% of hematopoietic bone marrow
• No concurrent palliative radiotherapy
• No concurrent anticancer radiotherapy

Surgery

• No concurrent anticancer surgery, including resection of any metastases

Other

• Recovered from prior therapy
• No concurrent combination anti-retroviral therapy for HIV-positive patients
• No other concurrent specific antitumor therapy
• No other concurrent investigational agents

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 normal
• AST and ALT ≤ 2.5 times upper limit of normal

Renal

• Creatinine ≤ 1.5 mg/dL

  OR

• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drug
• No ongoing or active infection
• No organ dysfunction or symptoms ≥ grade 2 (alopecia allowed)
• No psychiatric illness or social situation that would preclude study compliance
• No other uncontrolled illness

Expected Enrollment

Approximately 18-39 patients will be accrued for this study within 9-24 months.

Outline

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

Patients receive SJG-136 IV over 20 minutes once daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-6 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.

After completion of study treatment, patients are followed for 30 days.

Trial Contact Information

Trial Lead Organizations

Vanderbilt-Ingram Cancer Center

Igor Puzanov, MD, Principal investigator		Ph: 615-322-4967; 800-811-8480 Email: igor.puzanov@vanderbilt.edu

Registry Information
Official Title		A Phase I Dose Escalation Study of Daily x 3 Intravenous SJG-136 in Patients With Advanced Solid Tumors
Trial Start Date		2005-02-16
Trial Completion Date		2006-09-24 (estimated)
Registered in ClinicalTrials.gov		NCT00121290
Date Submitted to PDQ		2005-05-20
Information Last Verified		2008-04-18
NCI Grant/Contract Number		CA99177, CA68485