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A Phase I Trial of VNP40101M, a Novel Alkylating Agent, Administered Weekly for Patients With Advanced or Metastatic Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Trial of VNP40101M, a Novel Alkylating Agent, Administered Weekly for Patients With 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mario Sznol, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vion Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000258355

NCT ID:

NCT00049699

Start Date:

October 2002

Completion Date:

Related Keywords:

  • 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
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Neoplasm Metastasis
  • Lymphoma, Large-Cell, Immunoblastic
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Intestinal Neoplasms

Name

Location

Ireland Cancer CenterCleveland, Ohio  44106-5065
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Veterans Affairs Medical Center - West HavenWest Haven, Connecticut  06516