VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas

Sponsor

Vion Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00025129

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 solid tumors or lymphomas.

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 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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2001

Actual Study Completion Date :

May 1, 2004

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 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Clinical Research Center	Tucson	Arizona	United States	85712
2	Yale Comprehensive Cancer Center	New Haven	Connecticut	United States	06520-8028
3	Veterans Affairs Medical Center - West Haven	West Haven	Connecticut	United States	06516