Trial Outcomes & Findings for Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma (NCT NCT00591370)

NCT ID: NCT00591370

Last Updated: 2023-07-25

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 51 participants
• Primary outcome timeframe: From start of treatment through 24 weeks after ending treatment
• Results posted on: 2023-07-25

Participant Flow

Protocol Open to Accrual-01/12/2005 Protocol Closed to Accrual-11/27/2007 Primary Completion Date-06/10/2008 Recruitment Location is the medical clinic

Participant milestones

Measure	Temozolomide (TMZ) Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
Overall Study STARTED	51
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Temozolomide (TMZ) Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
Overall Study Not Treated	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Temozolomide (TMZ) n=51 Participants Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	27 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants

PRIMARY outcome

Timeframe: From start of treatment through 24 weeks after ending treatment

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.

Outcome measures

Measure	Temozolomide (TMZ) n=49 Participants Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
Determine the Overall Objective Response Rate (CR and PR). Complete Response	0 participants
Determine the Overall Objective Response Rate (CR and PR). Partial Response	6 participants
Determine the Overall Objective Response Rate (CR and PR). Stable Disease	16 participants
Determine the Overall Objective Response Rate (CR and PR). Progression of Disease	27 participants

SECONDARY outcome

Timeframe: 18 months after ending treatment

Overall survival at 18 months post treatment

Outcome measures

Measure	Temozolomide (TMZ) n=49 Participants Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
Overall Survival	27 percentage of participants

SECONDARY outcome

Timeframe: 24 weeks after ending treatment

Duration of Response (Objective Clinical Responses)

Outcome measures

Measure	Temozolomide (TMZ) n=6 Participants Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
Duration of Objective Clinical Responses	7.7 months Interval 4.3 to 11.1

Adverse Events

Temozolomide (TMZ)

Serious events: 7 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Temozolomide (TMZ) n=49 participants at risk Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
Gastrointestinal disorders Abdominal pain	2.0% 1/49 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment-related secondary malignancy	2.0% 1/49 • Number of events 1
Respiratory, thoracic and mediastinal disorders Epistaxis	2.0% 1/49 • Number of events 1
Metabolism and nutrition disorders Anorexia	2.0% 1/49 • Number of events 1
Gastrointestinal disorders Nausea	2.0% 1/49 • Number of events 1
Musculoskeletal and connective tissue disorders Pain in extremity	2.0% 1/49 • Number of events 1
Respiratory, thoracic and mediastinal disorders Respiratory disorder	2.0% 1/49 • Number of events 1
Investigations Lymphocyte count decrease	2.0% 1/49 • Number of events 1
Infections and infestations Skin infection	2.0% 1/49 • Number of events 1

Other adverse events

Measure	Temozolomide (TMZ) n=49 participants at risk Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
Investigations Lymphocyte count decrease	28.6% 14/49 • Number of events 14
Blood and lymphatic system disorders Anemia	12.2% 6/49 • Number of events 6
Investigations WBC/Neutropenia	6.1% 3/49 • Number of events 3
Gastrointestinal disorders Nausea/Vomiting	16.3% 8/49 • Number of events 8
Metabolism and nutrition disorders Anorexia	8.2% 4/49 • Number of events 4
Investigations Hyperbilirubinemia	10.2% 5/49 • Number of events 5
Metabolism and nutrition disorders Hyperglycemia	14.3% 7/49 • Number of events 7
General disorders Fatigue	14.3% 7/49 • Number of events 7
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.1% 3/49 • Number of events 3

Additional Information

Dr. Paul Chapman

Memorial Sloan-Kettering Cancer Center

Phone: 212-639-7357

Email: chapmanp@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place