VNP40101M in Treating Patients With Advanced or Metastatic Cancer

Sponsor

Vion Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00049699

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific	Drug: laromustine	Phase 1

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2002

Actual Study Completion Date :

Jan 1, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale Comprehensive Cancer Center	New Haven	Connecticut	United States	06520-8028
2	Veterans Affairs Medical Center - West Haven	West Haven	Connecticut	United States	06516
3	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065