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

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

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

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

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=99 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=99 Participants
Age, Categorical >=65 years	27 Participants n=99 Participants
Sex: Female, Male Female	18 Participants n=99 Participants
Sex: Female, Male Male	33 Participants n=99 Participants
Region of Enrollment United States	51 participants n=99 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

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). Stable Disease	16 participants
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). Progression of Disease	27 participants

SECONDARY outcome

Timeframe: 18 months after ending treatment

Overall survival at 18 months post treatment

Outcome measures

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

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

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

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: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place