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

Primary Purpose

Malignant Melanoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CC-5013
Sponsored by
Celgene
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma focused on measuring CC-5013, CC5013, celgene, Melanoma, Revlimid, Metastatic Malignant Melanoma, Lenalidomide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Understand and voluntarily sign an informed consent document Age greater than or equal to 18 years at the time of signing Informed Consent Be able to adhere to the study visit schedule and other protocol requirements Histological documentation of malignant melanoma with evidence of metastatic disease For the 10 patients enrolled at the MTD, at least one measurable lesion must be present (see Appendix II) ECOG performance status of 0, 1 or 2 (see Appendix I) Laboratory tests within these ranges: Absolute neutrophil count greater than or equal to 1,500/uL Platelet count greater than or equal to 100,000/uL Serum creatinine less than or equal to 1.5 mg/dL Total bilirubin less that or equal to 1.5 mg.dL AST (SGOT) / ALT (SGPT) less than or equal to to 2 times upper limit of normal (ULN) 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 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) Patients must be able to take medications orally Exclusion Criteria: Pregnant or lactating females 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. 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. 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. Use of thalidomide or biologic response modifier therapy within 14 days of Day 1, Cycle 1 Prior greater than or equal to grade 2 allergic reaction to thalidomide Prior desquamating rash while taking thalidomide Any prior use of lenalidomide Concurrent use of any other anti-cancer agents Radiation or surgical treatment of melanoma within 28 days of starting study treatment Active infection Central nervous system (CNS) metastases Patients with > grade-2 neuropathy Patients with known HIV positivity or AIDS-related illness

Sites / Locations

  • MD Anderson Cancer Center

Outcomes

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.

Full Information

First Posted
September 13, 2005
Last Updated
November 6, 2019
Sponsor
Celgene
Collaborators
Prologue Research International
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1. Study Identification

Unique Protocol Identification Number
NCT00179608
Brief Title
Study of the Combination of Lenalidomide and DTIC (Dacarbazine) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2005 (Actual)
Primary Completion Date
June 1, 2007 (Actual)
Study Completion Date
June 1, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
Collaborators
Prologue Research International

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma
Keywords
CC-5013, CC5013, celgene, Melanoma, Revlimid, Metastatic Malignant Melanoma, Lenalidomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CC-5013
Primary Outcome Measure Information:
Title
To determine MTD of intravenous DTIC during the first 2 cycles (6 wks) of treatment
Secondary Outcome Measure Information:
Title
To evaluate the safety profile of combination lenalidomide plus DTIC, the preliminary efficacy of combination lenalidomide plus DTIC
Title
To define the recommended phase II doses of lenalidomide and DTIC when administered as combination therapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Understand and voluntarily sign an informed consent document Age greater than or equal to 18 years at the time of signing Informed Consent Be able to adhere to the study visit schedule and other protocol requirements Histological documentation of malignant melanoma with evidence of metastatic disease For the 10 patients enrolled at the MTD, at least one measurable lesion must be present (see Appendix II) ECOG performance status of 0, 1 or 2 (see Appendix I) Laboratory tests within these ranges: Absolute neutrophil count greater than or equal to 1,500/uL Platelet count greater than or equal to 100,000/uL Serum creatinine less than or equal to 1.5 mg/dL Total bilirubin less that or equal to 1.5 mg.dL AST (SGOT) / ALT (SGPT) less than or equal to to 2 times upper limit of normal (ULN) 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 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) Patients must be able to take medications orally Exclusion Criteria: Pregnant or lactating females 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. 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. 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. Use of thalidomide or biologic response modifier therapy within 14 days of Day 1, Cycle 1 Prior greater than or equal to grade 2 allergic reaction to thalidomide Prior desquamating rash while taking thalidomide Any prior use of lenalidomide Concurrent use of any other anti-cancer agents Radiation or surgical treatment of melanoma within 28 days of starting study treatment Active infection Central nervous system (CNS) metastases Patients with > grade-2 neuropathy Patients with known HIV positivity or AIDS-related illness
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20859231
Citation
Hwu WJ, Knight RD, Patnana M, Bassett R, Papadopoulos NE, Kim KB, Hwu P, Bedikian A. Phase I safety study of lenalidomide and dacarbazine in patients with metastatic melanoma previously untreated with systemic chemotherapy. Melanoma Res. 2010 Dec;20(6):501-6. doi: 10.1097/CMR.0b013e32833faf18.
Results Reference
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Study of the Combination of Lenalidomide and DTIC (Dacarbazine) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy

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