VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas

Lymphoma Clinical Trial

Official title:

A Phase I Trial of VNP4010M, A Novel Alkylating Agent for Patients With Advanced or Metastatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00025129
• Other study ID #: VION-CLI-011
• Secondary ID: CDR0000068919NCI
• Status: Completed
• Phase: Phase 1
• First received: October 11, 2001
• Last updated: July 17, 2013
• Start date: March 2001
• Est. completion date: May 2004

Study information

• Verified date: March 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• laromustine

Locations

Country	Name	City	State
United States	Yale Comprehensive Cancer Center	New Haven	Connecticut
United States	Arizona Clinical Research Center	Tucson	Arizona
United States	Veterans Affairs Medical Center - West Haven	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Vion Pharmaceuticals

Country where clinical trial is conducted

United States,