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VNP40101M in Treating Patients With Advanced or Metastatic Cancer

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
laromustine
Sponsored by
Vion Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, intraocular lymphoma, primary central nervous system non-Hodgkin lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult T-cell leukemia/lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent mycosis fungoides/Sezary syndrome, small intestine lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Burkitt lymphoma, stage IV adult Hodgkin lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV adult T-cell leukemia/lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma, stage IV mycosis fungoides/Sezary syndrome, unspecified adult solid tumor, protocol specific, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Yale Comprehensive Cancer Center
  • Veterans Affairs Medical Center - West Haven
  • Ireland Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 12, 2002
Last Updated
July 17, 2013
Sponsor
Vion Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00049699
Brief Title
VNP40101M in Treating Patients With Advanced or Metastatic Cancer
Official Title
A Phase I Trial of VNP40101M, a Novel Alkylating Agent, Administered Weekly for Patients With Advanced or Metastatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2004
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vion Pharmaceuticals

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, intraocular lymphoma, primary central nervous system non-Hodgkin lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult T-cell leukemia/lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent mycosis fungoides/Sezary syndrome, small intestine lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Burkitt lymphoma, stage IV adult Hodgkin lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV adult T-cell leukemia/lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma, stage IV mycosis fungoides/Sezary syndrome, unspecified adult solid tumor, protocol specific, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
laromustine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Sznol, MD
Organizational Affiliation
Vion Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Yale Comprehensive Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8028
Country
United States
Facility Name
Veterans Affairs Medical Center - West Haven
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

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VNP40101M in Treating Patients With Advanced or Metastatic Cancer

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