A Multidose Phase I Study of Oral CC5013, a Thalidomide Derivative, in Patients With Refractory 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 Multidose Phase I Study of Oral CC5013, a Thalidomide Derivative, in Patients With Refractory Metastatic Cancer


OBJECTIVES:

- Determine the maximum tolerated dose of CC-5013 in patients with refractory solid
tumors and/or lymphoma.

- Characterize the pharmacokinetic profile of this drug in these patients.

- Determine whether any correlations can be made between plasma concentrations of this
drug and toxicity or clinical activity or biological activity in these patients.

- Characterize the side effect profile of this drug in these patients.

- Determine the dose-limiting toxicity of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oral CC-5013 on day 1. Within 4-10 days, patients begin second course and
receive oral CC-5013 once daily on days 1-21. Subsequent courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of CC-5013 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3
or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 3-51 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed refractory solid tumor and/or lymphoma

- No brain metastases or primary CNS malignancies

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- More than 3 months

Hematopoietic:

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin normal

- ALT and AST less than 2.5 times normal

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance greater than 60 mL/min

Cardiovascular:

- No unstable or newly diagnosed angina pectoris

- No myocardial infarction within the past 6 months

- No New York Heart Association class II, III, or IV congestive heart failure

Pulmonary:

- No chronic obstructive lung disease requiring oxygen therapy

Other:

- No uncontrolled seizures

- No concurrent acute critical illness

- No serious untreated infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months after study
participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior biologic therapy

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or
carboplatin)

- No concurrent cytotoxic chemotherapy

Endocrine therapy:

- At least 4 weeks since prior hormonal therapy

- Concurrent luteinizing hormone-releasing hormone agonist required in patients with
prostate cancer unless prior orchiectomy has been performed

Radiotherapy:

- At least 4 weeks since prior radiotherapy

Surgery:

- See Endocrine therapy

- Prior surgery allowed

Other:

- Recovered from prior therapy

- No concurrent anticonvulsants (e.g., phenobarbital, phenytoin, or carbamazepine)

- No concurrent rifampin

- No concurrent grapefruit juice

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

William Dahut, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Medical Oncology Branch

Authority:

United States: Federal Government

Study ID:

020083

NCT ID:

NCT00031941

Start Date:

April 2002

Completion Date:

April 2009

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
  • 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
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • anaplastic large cell lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • small intestine lymphoma
  • 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
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182
NCI - Center for Cancer Research Bethesda, Maryland  20892