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A Phase I Trial of VNP4010M, A Novel Alkylating Agent 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 VNP4010M, A Novel Alkylating Agent for Patients With Advanced or Metastatic Cancer


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.

Inclusion 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)

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:

CDR0000068919

NCT ID:

NCT00025129

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Lymphoma
  • Small Intestine Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Intestinal Neoplasms

Name

Location

Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Arizona Clinical Research CenterTucson, Arizona  85712
Veterans Affairs Medical Center - West HavenWest Haven, Connecticut  06516