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VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas

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 stage IV adult Hodgkin lymphoma, recurrent adult Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, small intestine lymphoma, unspecified adult solid tumor, protocol specific, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV adult Burkitt lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, stage IV adult T-cell leukemia/lymphoma, recurrent adult T-cell leukemia/lymphoma, primary central nervous system non-Hodgkin lymphoma, intraocular lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, stage IV mycosis fungoides/Sezary syndrome, recurrent mycosis fungoides/Sezary syndrome, 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 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)

Sites / Locations

  • Arizona Clinical Research Center
  • Yale Comprehensive Cancer Center
  • Veterans Affairs Medical Center - West Haven

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 11, 2001
Last Updated
July 17, 2013
Sponsor
Vion Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00025129
Brief Title
VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas
Official Title
A Phase I Trial of VNP4010M, A Novel Alkylating Agent 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
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (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 solid tumors or lymphomas.
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.

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
stage IV adult Hodgkin lymphoma, recurrent adult Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, small intestine lymphoma, unspecified adult solid tumor, protocol specific, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV adult Burkitt lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, stage IV adult T-cell leukemia/lymphoma, recurrent adult T-cell leukemia/lymphoma, primary central nervous system non-Hodgkin lymphoma, intraocular lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, stage IV mycosis fungoides/Sezary syndrome, recurrent mycosis fungoides/Sezary syndrome, 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 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)
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
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
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

12. IPD Sharing Statement

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VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas

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