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VNP40101M in Treating Patients With Advanced or Metastatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00049699
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : October 2002
Actual Study Completion Date : January 2008

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049699


Locations
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United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
Veterans Affairs Medical Center - West Haven
West Haven, Connecticut, United States, 06516
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Vion Pharmaceuticals
Investigators
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Study Chair: Mario Sznol, MD Vion Pharmaceuticals
More Information
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ClinicalTrials.gov Identifier: NCT00049699    
Other Study ID Numbers: VION-CLI-028
CDR0000258355 ( Registry Identifier: PDQ (Physician Data Query) )
YALE-HIC-16775
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: March 2004
Keywords provided by National Cancer Institute (NCI):
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
Additional relevant MeSH terms:
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Lymphoma
Neoplasm Metastasis
Intestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Neoplastic Processes
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases