VNP40101M in Treating Patients With Advanced or Metastatic Cancer

Lymphoma Clinical Trial

Official title:

A Phase I Trial of VNP40101M, a Novel Alkylating Agent, Administered Weekly for Patients With Advanced or Metastatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00049699
• Other study ID #: VION-CLI-028
• Secondary ID: CDR0000258355YAL
• Status: Completed
• Phase: Phase 1
• First received: November 12, 2002
• Last updated: July 17, 2013
• Start date: October 2002
• Est. completion date: January 2008

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 or metastatic cancer.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• laromustine

Locations

Country	Name	City	State
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Yale Comprehensive Cancer Center	New Haven	Connecticut
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,