VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas

NCT ID: NCT00025129

Last Updated: 2013-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-03-31
• Study Completion Date: 2004-05-31

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 solid tumors or lymphomas.

Detailed Description

OBJECTIVES:

• Determine the maximum tolerated dose of VNP40101M in patients with advanced solid tumors or lymphomas.
• Determine the toxic effects of this drug in these patients.
• Determine the pharmacokinetics of this drug in these patients.
• Determine the anti-tumor effects of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive VNP40101M IV over 15 minutes on day 1. Treatment repeats every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 20-30 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 and/or metastatic solid tumor or lymphoma for which no curative or standard effective therapy exists
• Measurable or evaluable metastatic disease
• No other hematologic malignancy
• No large pleural, pericardial, or peritoneal effusions
• No requirement for immediate palliative treatment, including surgery
• No symptomatic brain metastases or metastases with substantial edema

• Asymptomatic brain metastases or primary CNS disease allowed if neurologic deficits are stable

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 active uncontrolled bleeding

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• ALT and AST no greater than 1.5 times ULN (3 times ULN if liver metastases present)
• Alkaline phosphatase no greater than 1.5 times ULN (3 times ULN if liver or bone metastases present)
• PT and aPTT no greater than 1.5 times ULN
• Albumin at least 2.5 g/dL

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• Ejection fraction at least 45%
• No active heart disease
• No myocardial infarction within the past 3 months
• No symptomatic coronary artery disease
• No arrhythmias requiring medication
• No uncontrolled congestive heart failure

Pulmonary:

• DLCO and FEV_1 at least 60% of predicted
• No dyspnea with minimal to moderate exertion

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study participation
• HIV negative
• No active infection
• Persistent stable chronic toxic effects from prior therapy allowed if no greater than grade 1
• No bleeding diathesis (e.g., active peptic ulcer disease)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior biologic agents and recovered
• At least 6 months since prior high-dose chemotherapy regimen with stem cell support

Chemotherapy:

• See Biologic therapy
• At least 3 weeks since prior cytotoxic agents (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

• At least 2 weeks since prior hormonal therapy and recovered

Radiotherapy:

• At least 3 weeks since prior radiotherapy and recovered

Surgery:

• See Disease Characteristics
• At least 2 weeks since prior surgery and recovered

Other:

• No other concurrent standard therapy for cancer
• No other concurrent investigational agents
• No concurrent disulfiram (Antabuse)

• 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

Arizona Clinical Research Center

Tucson, Arizona, United States

Yale Comprehensive Cancer Center

New Haven, Connecticut, United States

Veterans Affairs Medical Center - West Haven

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

CDR0000068919

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-V01-1669

Identifier Type: -

Identifier Source: secondary_id

VION-CLI-011

Identifier Type: -

Identifier Source: org_study_id