CC-4047 in Treating Patients With Advanced Solid Tumors That Did Not Respond to Treatment - Full Text View

Purpose

RATIONALE: CC-4047 may stop the growth of tumor cells by blocking blood flow to the tumor.

PURPOSE: This phase I trial is studying the side effects and best dose of CC-4047 in treating patients with advanced solid tumors that did not respond to treatment.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: CC-4047	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Pomalidomide

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:

Maximum tolerated dose [ Time Frame: after initial 28 day cycle ] [ Designated as safety issue: Yes ]
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).
Dose-limiting toxicity [ Time Frame: Courses repeat every 28 days for up to 24 months in the absence of unacceptable toxicity. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Tumor response as assessed by RECIST criteria [ Time Frame: after every 2 courses (28 days/ course) ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: Courses repeat every 28 days for up to 24 months in the absence of disease progression. ] [ Designated as safety issue: No ]
Fetal hemoglobin levels as assessed thereafter [ Time Frame: at baseline and every 28 days thereafter ] [ Designated as safety issue: No ]

Enrollment:	42
Study Start Date:	March 2007
Study Completion Date:	August 2012
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CC-4047	Drug: CC-4047 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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482521

Locations

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

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:	Matthew M. Cooney, MD	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Principal Investigator:	Robert Dreicer, MD	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00482521 History of Changes
Other Study ID Numbers:	CASE4Y06, P30CA043703, CASE4Y06
Study First Received:	June 4, 2007
Last Updated:	August 27, 2012
Health Authority:	United States: Federal Government United States: Food and Drug Administration

Keywords provided by Case Comprehensive Cancer Center:

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013