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A Phase I, Open-Label Study to Determine the Maximum Tolerated Dose (MTD) and to Evaluate the Safety Profile of CC-4047 in Subjects With Advanced Solid Tumors


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

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Trial Information

A Phase I, Open-Label Study to Determine the Maximum Tolerated Dose (MTD) and to Evaluate the Safety Profile of CC-4047 in Subjects With Advanced Solid Tumors


OBJECTIVES:

Primary

- Determine the maximum tolerated dose of CC-4047 in patients with advanced refractory
solid tumors.

Secondary

- Assess the safety of this drug in these patients.

- Assess the antitumor activity of this drug in these patients.

- Determine the effect of this drug on fetal hemoglobin levels in these patients.

OUTLINE: This is a open-label, uncontrolled, nonrandomized, dose-escalation, multicenter
study.

- Treatment phase (course 1): Patients receive oral CC-4047 once daily on days 1-21
followed by a 7-day recovery period.

Cohorts of 3-6 patients receive escalating doses of CC-4047 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity (DLT).

Patients with no clinical evidence of progressive disease or DLT after course 1 continue
study treatment during the extension phase. Patients who develop a DLT during course 1 may
continue study treatment at the discretion of the investigator.

- Extension phase: Patients continue taking CC-4047 at their assigned cohort dose as in
course 1. Patients who tolerate a treatment-phase dose higher than the MTD continue
treatment at the MTD. Courses repeat every 28 days for up to 24 months in the absence
of disease progression or unacceptable toxicity.

Patients undergo blood collection at baseline and periodically during study to evaluate
fetal hemoglobin levels.

After completion of study treatment, patients are followed at 28 days.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed advanced solid tumor

- Refractory disease

- Patients must have been offered and refused OR received and failed prior
treatment with all standard or approved therapies for the malignancy

- Measurable or evaluable disease as confirmed by radiographic or clinical evidence

- No curative therapy available

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy ≥ 3 months

- ANC > 1,500/mm³

- Platelet count > 75,000/mm³

- Hemoglobin ≥ 9.0 g/dL

- Creatinine ≤ 2.0 mg/dL

- AST and ALT < 3 times upper limit of normal

- Not pregnant

- No nursing during and for ≥ 28 days after completion of study treatment

- Two negative pregnancy tests required

- Fertile women must use effective double-method contraception for ≥ 28 days before,
during, and for ≥ 28 days after completion of study treatment

- Men must use a latex condom during sexual contact with fertile females during and for
≥ 28 days after completion of study treatment, even if a prior successful vasectomy
was performed

- Stable neurological exam

- No serious medical condition or psychiatric illness that would preclude study
participation

- No prior desquamating rash or allergic reaction ≥ grade 2 while taking thalidomide,
lenalidomide, or structurally related compounds

- No peripheral neuropathy ≥ grade 2

- No active infection

- No uncontrolled hyper- or hypocalcemia, glycosemia, or thyroidism

PRIOR CONCURRENT THERAPY:

- No prior CC-4047

- More than 28 days since prior cytotoxic chemotherapy (42 days for nitrosoureas)

- At least 14 days since prior therapeutic radiotherapy

- More than 14 days since prior thalidomide, lenalidomide, or structurally related
compounds

- More than 14 days since prior biological response modifier therapy

- Concurrent radiotherapy to treat pain associated with existing bone lesions during
the extension phase of the study allowed provided < 10% of bone marrow is irradiated

- Concurrent systemic steroids for control of CNS primary tumor and/or metastases
symptoms allowed provided dose is stable or decreasing AND patient is also taking
low-dose aspirin and/or other platelet-active, anti-thrombotic medication during and
for 30 days after completion of study treatment

- No other concurrent chemotherapy or immunotherapy

- No other concurrent investigational agents

- No concurrent hematopoietic growth factors during the treatment phase of the study

- No other concurrent anticancer agents

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Description:

To determine the maximum tolerated dose (MTD) of daily CC-4047 in an initial 28-day cycle (21 days of CC-4047 followed by 7 days of no therapy) in subjects with advanced solid tumors (Cohort A).

Outcome Time Frame:

after initial 28 day cycle

Safety Issue:

Yes

Principal Investigator

Matthew M. Cooney, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CASE4Y06

NCT ID:

NCT00482521

Start Date:

March 2007

Completion Date:

August 2012

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195