VNP40101M in Treating Patients With Advanced or Metastati... | NCT00049699 | TrialantNCT00049699- Lymphoma
- Small Intestine Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
Obsolete or Duplicate NCT IDs Not provided
| ID | Type | Description | Link |
|---|
| CDR0000258355 | Registry Identifier | PDQ (Physician Data Query) | |
| YALE-HIC-16775 | | | |
VNP40101M in Treating Patients With Advanced or Metastatic Cancer
A Phase I Trial of VNP40101M, a Novel Alkylating Agent, Administered Weekly for Patients With Advanced or Metastatic Cancer
National Cancer Institute (NCI)NIH
Overall Recruitment Status or Expanded Access Status Completed
First Submission Date that Met QC Criteria Jan 26, 2003
Results First Submitted Date Not provided
Results First Submitted that Met QC Criteria Not provided
Results First Posted Date Not provided
Certification/Extension (aka Delayed Results) First Submitted Date Not provided
Certification/Extension First Submitted that Passed QC Review Not provided
Certification/Extension First Posted Date Not provided
Last Update Submitted Date Jul 17, 2013
Responsible Party, by Official Title Not provided
Vion PharmaceuticalsINDUSTRY
No data available
No data is available for this block.
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.
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.
- Lymphoma
- Small Intestine Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
- 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
Number of References to an Expanded Access Study Not provided
Target Follow-Up Duration Not provided
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No data is available for this block.
| Name | Type | Description | Arm Group Labels | Other Names |
|---|
| laromustine | Drug | | | |
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No data is available for this block.
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
Performance status
Life expectancy
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
Accepts Healthy Volunteers No
| Name | Affiliation | Role |
|---|
| Mario Sznol, MD | Vion Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|
| Yale Comprehensive Cancer Center | | New Haven | Connecticut | 06520-8028 | United States | |
| Veterans Affairs Medical Center - West Haven |
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| ID | Term |
|---|
| D008223 | Lymphoma |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D007119 | Immunoblastic Lymphadenopathy |
| D064090 | Intraocular Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D002051 | Burkitt Lymphoma |
| D006689 | Hodgkin Disease |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
|
| ID | Term |
|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
recurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent mycosis fungoides/Sezary syndromesmall intestine lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Burkitt lymphomastage IV adult Hodgkin lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult T-cell leukemia/lymphomastage IV cutaneous T-cell non-Hodgkin lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV mycosis fungoides/Sezary syndromeunspecified adult solid tumor, protocol specificrecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomaIntervention Model Description Not provided
No data available
No data is available for this block.
| Ireland Cancer Center | | Cleveland | Ohio | 44106-5065 | United States | |
| Leukemia, Lymphocytic, Chronic, B-Cell |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000072281 | Lymphadenopathy |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014412 | Tumor Virus Infections |
| D007945 | Leukemia, Lymphoid |
| D006402 | Hematologic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |