Phase 1 Study OF CDC-501 in Patients With Solid Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Celgene Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00046735
First received: October 2, 2002
Last updated: September 30, 2009
Last verified: September 2009
  Purpose

To identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week cycle in patients with solid tumors that are refractory after standard treatment.


Condition Intervention Phase
Neoplasms
Drug: Lenalidomide
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-Center, Open-Label, Between-Patient, Dose-Escalation Phase 1 Study of CDC-501 In Patients With Solid Tumors

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • To identify the MTD and safety of CDC-501 when given in a 6-wk cycle of daily administration of CDC-501 for 4 wks followed by a 2-wk rest in doses of 5 mg/day up to 25 mg/day in pts with solid tumors that are refractory after standard treatment. [ Time Frame: 6-week cycle comprising daily administration of CDC-501 for 4 weeks followed by a 2-week rest ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: June 2002
Estimated Study Completion Date: December 2009
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Lenalidomide
The planned doses for investigation are as follows: 5, 10, and 25 mg/day. Lenalidomide will be administered as a single daily dose for 4 weeks followed by a 2-week rest period. Dosing will be in the morning at approximately the same time each day, at least 1 hour before the morning meal. Patients will be assigned to dose level in the order of study entry. No dose adjustments or suspensions are allowed during the first cycle, except discontinuation for DLT

Detailed Description:

Identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week cycle in patients with solid tumors that are refractory after standard treatment

  Eligibility

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

Inclusion Criteria:

  1. Patient must understand and voluntarily sign an informed consent document.
  2. Age 18 years at the time of signing Informed Consent
  3. Histologically or cytologically documented solid tumors that are refractory to standard/conventional therapy or for which no standard/conventional therapy exists.
  4. Patients must have at least one measurable or non-measurable lesion according to the RECIST Criteria (Appendix I).
  5. Patient has an ECOG (Zubrod) performance status of ≤ 2.
  6. Approximate life expectancy greater than 3 months.
  7. Laboratory tests within these ranges:

    • Absolute neutrophil count ≥ 1,500/μlL
    • Platelet count ≥100,000/μL
    • Serum creatinine ≤1.5 mg/dL
    • Total bilirubin ≤1.5 mg/dL
    • AST (SGOT)/ALT(SGPT) ≤ 2 x upper limit of normal (ULN) or ≤ 5 x ULN if hepatic metastases present
  8. The following prior treatments are allowable under this protocol:
  9. Radiation, if discontinued at least 4 weeks prior to treatment under this protocol Chemotherapy, if discontinued at least 4 weeks prior to treatment under this protocol, and at least 6 weeks prior to treatment under this protocol for prior nitrosurea or mitomycin-C treatment
  10. Hormonal therapy for cancer, if discontinued at least 4 weeks prior to treatment under this protocol
  11. Other investigational drugs, if discontinued at least 4 weeks prior to treatment under this protocol
  12. Surgery, if minor surgery occurred at least 2 weeks prior to treatment under this protocol, or at least 4 weeks since major surgery
  13. Patient must be able to adhere to the study visit schedule and other protocol requirements.
  14. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days prior to baseline. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).

Exclusion Criteria

  1. Myocardial infarction within the previous 6 months, unstable angina,symptomatic congestive heart failure, or other significant uncontrolled cardiac arrhythmia.
  2. Cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or other significant thromboembolic event in the previous 6 months.
  3. Active infection, including known human immunodeficiency virus (HIV) positivity or acquired-immunodeficiency-syndrome (AIDS)-related illness.
  4. CNS metastases, unless controlled by previous radiation and the patient is neurologically stable.
  5. Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the patient from signing the informed consent or limit survival to less than 3 months.
  6. Pregnant or nursing females.Female patients of childbearing potential who are unwilling to use reliable contraceptive methods.
  7. Any condition, including the presence of laboratory abnormalities, which in the opinion of the Investigator places the patient at unacceptable risk if he/she were to participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046735

Locations
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Robert Knight, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Robert Knight, VP Hematology, Celgene Corporation
ClinicalTrials.gov Identifier: NCT00046735     History of Changes
Other Study ID Numbers: CC-5013-ST-003
Study First Received: October 2, 2002
Last Updated: September 30, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
solid tumors
Revimid
CC5013
CC-5013

Additional relevant MeSH terms:
Neoplasms
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014