Study of the Combination of Lenalidomide and DTIC (Dacarbazine) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
Prologue Research International
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00179608
First received: September 13, 2005
Last updated: January 8, 2010
Last verified: January 2010
  Purpose

This study will determine the MDT of intravenous DTIC when administered in combination with a fixed dose of oral lenalidomide in subjects with metastatic malignant melanoma previously untreated with systemic chemotherapy. This study will evaluate the safety and preliminary efficacy of the combination of lenalidomide and DTIC. Subjects will be receive lenalidomide for 14 consecutive days and DTIC on day one of each 21 day cycle.


Condition Intervention Phase
Malignant Melanoma
Drug: CC-5013
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: Phase I Safety Study of the Combination of Lenalidomide and DTIC (Dacarbazine) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • To determine MTD of intravenous DTIC during the first 2 cycles (6 wks) of treatment

Secondary Outcome Measures:
  • To evaluate the safety profile of combination lenalidomide plus DTIC, the preliminary efficacy of combination lenalidomide plus DTIC
  • To define the recommended phase II doses of lenalidomide and DTIC when administered as combination therapy.

Estimated Enrollment: 28
Study Start Date: September 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  1. Understand and voluntarily sign an informed consent document
  2. Age greater than or equal to 18 years at the time of signing Informed Consent
  3. Be able to adhere to the study visit schedule and other protocol requirements
  4. Histological documentation of malignant melanoma with evidence of metastatic disease
  5. For the 10 patients enrolled at the MTD, at least one measurable lesion must be present (see Appendix II)
  6. ECOG performance status of 0, 1 or 2 (see Appendix I)
  7. Laboratory tests within these ranges:

    1. Absolute neutrophil count greater than or equal to 1,500/uL
    2. Platelet count greater than or equal to 100,000/uL
    3. Serum creatinine less than or equal to 1.5 mg/dL
    4. Total bilirubin less that or equal to 1.5 mg.dL
    5. AST (SGOT) / ALT (SGPT) less than or equal to to 2 times upper limit of normal (ULN)
  8. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug.

    In addition, sexually active WCBP must agree to use at least two methods of adequate contraceptive (oral, injectable, or implantable hormonal contraceptive, tubal ligation, intra-uterine device, barrier contraceptive with spermicide, contraceptive skin patch or vasectomized partner) while on study drug

  9. All acute adverse effects (excluding alopecia of any prior therapy must have resolved to less than or equal to grade 1 (NCI CTCAE v3.0)
  10. Patients must be able to take medications orally

Exclusion Criteria:

  1. Pregnant or lactating females
  2. Any serious medical condition, including psychiatric illnesses that will prevent the patient from signing the informed consent or place the patient at an unacceptable risk if he/she participates in the study.
  3. Prior treatment with systemic chemotherapy. Patients who have received prior immunotherapy, including thalidomide, or radiotherapy remain eligible.

    Lesions within a prior field of radiation may only be used as indicator lesions if there has been evidence of disease progression at that site.

  4. Prior history of malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the patient has been free of the disease for at least 3 years.
  5. Use of thalidomide or biologic response modifier therapy within 14 days of Day 1, Cycle 1
  6. Prior greater than or equal to grade 2 allergic reaction to thalidomide
  7. Prior desquamating rash while taking thalidomide
  8. Any prior use of lenalidomide
  9. Concurrent use of any other anti-cancer agents
  10. Radiation or surgical treatment of melanoma within 28 days of starting study treatment
  11. Active infection
  12. Central nervous system (CNS) metastases
  13. Patients with > grade-2 neuropathy
  14. Patients with known HIV positivity or AIDS-related illness
  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: NCT00179608

Locations
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Celgene Corporation
Prologue Research International
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00179608     History of Changes
Other Study ID Numbers: CC-5013-MEL-003
Study First Received: September 13, 2005
Last Updated: January 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
CC-5013
CC5013
celgene
Melanoma
Revlimid
Metastatic Malignant Melanoma
Lenalidomide

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Dacarbazine
Lenalidomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014