Trial Outcomes & Findings for FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma (NCT NCT00104884)

Last Updated: 2023-06-28

Results Overview

Response is evaluated using Solid Tumor Response Criteria (RECIST) and defined as either complete repose (CR) or partial response (PR). Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least 30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 3 years from study entry, up to 3 years

Results posted on

2023-06-28

Participant Flow

The study was activated on January 11, 2005, accrued its first patient on October 4, 2005, and terminated on May 17, 2006 due to slow accrual. Four patients were enrolled.

Participant milestones

Participant milestones
Measure	Depsipeptide Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m\^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Depsipeptide Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m\^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
Overall Study Disease progression	4

Baseline Characteristics

FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Depsipeptide n=4 Participants Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m\^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
Age, Continuous	53.5 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 3 years from study entry, up to 3 years

Population: The study was terminated early due to slow accrual with final accrual of 4 patients. There are no plans to conduct a formal analysis for any outcome measure.

Outcome measures

Outcome measures
Measure	Depsipeptide n=4 Participants Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m\^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
Proportion of Patients With Response to Depsipeptide	NA percentage of participants The study was terminated early due to slow accrual with final accrual of 4 patients. There are no plans to conduct a formal analysis for any outcome measure.

Adverse Events

Depsipeptide

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Depsipeptide n=4 participants at risk Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m\^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
Metabolism and nutrition disorders Hypocalcemia	25.0% 1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment Submission of late adverse events is required at follow-up visits up to 3 years .

Other adverse events

Other adverse events
Measure	Depsipeptide n=4 participants at risk Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m\^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
Blood and lymphatic system disorders Anemia	75.0% 3/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment Submission of late adverse events is required at follow-up visits up to 3 years .
Investigations Platelets decreased	50.0% 2/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment Submission of late adverse events is required at follow-up visits up to 3 years .
General disorders Fatigue	75.0% 3/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment Submission of late adverse events is required at follow-up visits up to 3 years .
Metabolism and nutrition disorders Anorexia	25.0% 1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment Submission of late adverse events is required at follow-up visits up to 3 years .
Gastrointestinal disorders Nausea	75.0% 3/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment Submission of late adverse events is required at follow-up visits up to 3 years .
Gastrointestinal disorders Vomiting	50.0% 2/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment Submission of late adverse events is required at follow-up visits up to 3 years .
Infections and infestations Infection w/ unk ANC urinary tract NOS	25.0% 1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment Submission of late adverse events is required at follow-up visits up to 3 years .
Metabolism and nutrition disorders Hypoalbuminemia	75.0% 3/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment Submission of late adverse events is required at follow-up visits up to 3 years .
Investigations Alkaline phosphatase increased	25.0% 1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment Submission of late adverse events is required at follow-up visits up to 3 years .
Metabolism and nutrition disorders Hypocalcemia	50.0% 2/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment Submission of late adverse events is required at follow-up visits up to 3 years .
Investigations Creatinine increased	75.0% 3/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment Submission of late adverse events is required at follow-up visits up to 3 years .
Metabolism and nutrition disorders Hyperglycemia	50.0% 2/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment Submission of late adverse events is required at follow-up visits up to 3 years .
Metabolism and nutrition disorders Hyponatremia	25.0% 1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment Submission of late adverse events is required at follow-up visits up to 3 years .

Additional Information

Study Statistician

ECOG-ACRIN Statistical Office

Phone: 617-632-3012

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60