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Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma

Primary Purpose

Melanoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Temozolomide (TMZ)

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Memorial Sloan-Kettering Cancer Center patients with measurable, unresectable stage, III or IV melanoma

Eligibility Criteria

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

Inclusion Criteria:

Stage III (unresectable) or Stage IV melanoma from a cutaneous or an unknown primary.
Histologic proof of melanoma reviewed and confirmed at MSKCC
Measurable disease (RECIST criteria)
No prior chemotherapy for melanoma. Prior interferon, interleukin-2 or vaccine therapy are allowed.
No other concurrent chemotherapy, immunotherapy, or radiotherapy
Karnofsky performance status ≥ 60
Adequate organ function defined as follows: ANC > 1500, Platelets > 100,000, creatinine < 2, Alkaline Phosphatase, AST and total bilirubin < 1.5x upper limit of normal. For patients with suspected Gilbert's syndrome bilirubin will not be a requirement.
Tumor tissue for MGMT promoter methylation analysis and/or IHC must be available. In most cases, this will be unstained slides from previously-obtained paraffin-embedded tumor material. If this is not available, patients must have an easily-accessable tumor for biopsy (e.g. skin or lymph node).

Exclusion Criteria:

History of CNS metastases unless brain metastases have been resected and the patient has been free from CNS recurrence for 6 months.
Uveal or mucosal melanoma primary
Frequent vomiting or medical conditions that could interfere with oral medication intake
Serious infection requiring antibiotics, or nonmalignant medical illnesses that are uncontrolled or whose control might be jeopardized by the complications of this therapy.
History of HIV infection even if on HAART
Immunosuppressive drugs
High dose vitamins and herbs
Other on-going investigational therapy, concurrent chemotherapy, immunotherapy or radiotherapy.

Sites / Locations

Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1 - Temozolomide (TMZ)

Arm Description

Outcomes

Primary Outcome Measures

Determine the Overall Objective Response Rate (CR and PR).

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Secondary Outcome Measures

Overall Survival

Overall survival at 18 months post treatment

Duration of Objective Clinical Responses

Duration of Response (Objective Clinical Responses)

Full Information

NCT ID

NCT00591370

First Posted

December 26, 2007

Last Updated

July 10, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Schering-Plough

1. Study Identification

Unique Protocol Identification Number

NCT00591370

Brief Title

Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma

Official Title

Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Schering-Plough

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Temozolomide (also known as TMZ) is a chemotherapy drug given by mouth. It is similar to DTIC, the only FDA-approved chemotherapy for melanoma, but because temozolomide is given by mouth, it can be given daily over a long period of time. We think that temozolomidemay work best if it is given every day for 6 weeks at a time. Temozolomide given by this extended schedule is experimental, although we have found that it is safe and can shrink melanoma in some patients. One big advantage of TMZ is that it is given by mouth instead of by vein. This means that it can be given daily over a long period of time rather than off and on like DTIC. We think that TMZ may work better if it is given every day for 6 weeks. TMZ given by this extended schedule is experimental although we have found that TMZ given in this way is safe and can shrink melanoma in some patients. When extended dosing TMZ was given with either thalidomide or long-acting interferon-α, about 30% of patients had their tumors shrink. We think that this shrinkage was due mostly to the TMZ since neither thalidomide nor interferon-α alpha work in melanoma by themselves. In this study, we will treat patients with TMZ alone using this extended dosing schedule to see how many patients experience tumor shrinkage. We also want to learn more about which tumors are more likely to shrink from TMZ treatment. We will test samples of your tumor for whether or not a gene called MGMT has been turned on,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

Memorial Sloan-Kettering Cancer Center patients with measurable, unresectable stage, III or IV melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 - Temozolomide (TMZ)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Temozolomide (TMZ)

Intervention Description

One group treatment study

Primary Outcome Measure Information:

Title

Determine the Overall Objective Response Rate (CR and PR).

Description

Time Frame

From start of treatment through 24 weeks after ending treatment

Secondary Outcome Measure Information:

Title

Overall Survival

Description

Overall survival at 18 months post treatment

Time Frame

18 months after ending treatment

Title

Duration of Objective Clinical Responses

Description

Duration of Response (Objective Clinical Responses)

Time Frame

24 weeks after ending treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Stage III (unresectable) or Stage IV melanoma from a cutaneous or an unknown primary. Histologic proof of melanoma reviewed and confirmed at MSKCC Measurable disease (RECIST criteria) No prior chemotherapy for melanoma. Prior interferon, interleukin-2 or vaccine therapy are allowed. No other concurrent chemotherapy, immunotherapy, or radiotherapy Karnofsky performance status ≥ 60 Adequate organ function defined as follows: ANC > 1500, Platelets > 100,000, creatinine < 2, Alkaline Phosphatase, AST and total bilirubin < 1.5x upper limit of normal. For patients with suspected Gilbert's syndrome bilirubin will not be a requirement. Tumor tissue for MGMT promoter methylation analysis and/or IHC must be available. In most cases, this will be unstained slides from previously-obtained paraffin-embedded tumor material. If this is not available, patients must have an easily-accessable tumor for biopsy (e.g. skin or lymph node). Exclusion Criteria: History of CNS metastases unless brain metastases have been resected and the patient has been free from CNS recurrence for 6 months. Uveal or mucosal melanoma primary Frequent vomiting or medical conditions that could interfere with oral medication intake Serious infection requiring antibiotics, or nonmalignant medical illnesses that are uncontrolled or whose control might be jeopardized by the complications of this therapy. History of HIV infection even if on HAART Immunosuppressive drugs High dose vitamins and herbs Other on-going investigational therapy, concurrent chemotherapy, immunotherapy or radiotherapy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Chapman, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan-Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan-Kettering Cancer Center

Learn more about this trial

Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma

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