VNP40101M in Treating Patients With Advanced or Metastatic Cancer

NCT ID: NCT00049699

Last Updated: 2013-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2008-01-31

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have advanced or metastatic cancer.

Detailed Description

OBJECTIVES:

• Determine the toxic effects of VNP40101M in patients with advanced or metastatic solid tumor or lymphoma.
• Determine the maximum tolerated dose of this drug in these patients.
• Determine the pharmacokinetics of this drug in these patients.
• Determine the antitumor effects of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive VNP40101M IV over 15 minutes on days 1, 8, and 15. Treatment repeats every 28 days.

Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose is determined.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.

Conditions

Lymphoma; Small Intestine Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT

Interventions

laromustine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed advanced or metastatic solid tumor or lymphoma for which no curative or standard effective therapy exists
• Measurable or evaluable disease
• Primary brain tumors or brain metastases allowed provided neurologic deficits are stable and do not preclude study compliance

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• At least 3 months

Hematopoietic

• Granulocyte count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hematocrit at least 30% (transfusion allowed)
• No bleeding diathesis

Hepatic

• PT and PTT no greater than 1.5 times the upper limit of normal (ULN)
• Bilirubin no greater than 1.5 times ULN
• ALT and AST no greater than 1.5 times ULN (3 times ULN if liver metastases present)
• Albumin at least 2.5 gm/dL

Renal

• Creatinine no greater than 2.0 mg/dL

Cardiovascular

• At least 3 months since prior myocardial infarction
• No symptomatic coronary artery disease
• No arrhythmias requiring medication
• No uncontrolled congestive heart failure

Pulmonary

• No dyspnea on minimal or moderate exertion
• DLCO and FEV1 at least 60% predicted

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No uncontrolled active bleeding (e.g., active peptic ulcer disease)
• No active infection
• HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Recovered from acute toxicities of prior biologic therapy (persisting, chronic toxicity allowed if stable and no greater than grade 1)

Chemotherapy

• More than 6 months since prior high-dose chemotherapy with stem cell support
• More than 3 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas)
• Recovered from acute toxicities of prior chemotherapy (persisting, chronic toxicity allowed if stable and no greater than grade 1)

Endocrine therapy

• At least 2 weeks since prior hormonal therapy

Radiotherapy

• Recovered from acute toxicities of prior radiotherapy (persisting, chronic toxicity allowed if stable and no greater than grade 1)

Surgery

• At least 2 weeks since prior surgery

Other

• No other concurrent standard or investigational treatment for cancer
• No concurrent disulfiram

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vion Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

Mario Sznol, MD

Role: STUDY_CHAIR

Vion Pharmaceuticals

Locations

Yale Comprehensive Cancer Center

New Haven, Connecticut, United States

Veterans Affairs Medical Center - West Haven

West Haven, Connecticut, United States

Ireland Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CDR0000258355

Identifier Type: REGISTRY

Identifier Source: secondary_id

YALE-HIC-16775

Identifier Type: -

Identifier Source: secondary_id

VION-CLI-028

Identifier Type: -

Identifier Source: org_study_id