Pilot Study to Evaluate the Effects of a Vaccine (HSPPC-96) Combined With Ipilimumab in Patients With Advanced Melanoma

Part of paid clinical trials in Houston, Texas.

Sponsor
Rabih Said
Study ID
NCT02452281
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ipilimumab — DRUG
    3 mg/kg, IV one day (a minimum of 12 hours and not more than 48 hours) before HSPPC-96 every 21-25 days for a total of 4 cycles.
  • HSPPC-96 — DRUG
    25 μg by intradermal injection always 12 - 48 hours following ipilimumab on a weekly basis for the first 4 weeks and then every 3 weeks always 12 - 48 hours after ipilimumab; for at least 6 cycles of HSPPC-96 up to 12 doses.

Study Details

The purpose of this research study is to see if the combination of HSPPC-96 and ipilimumab is safe and effective in the treatment of advanced melanoma. HSPPC-96 is an investigational vaccine created from tissue from the patient's tumor. The vaccine is designed to capture the cancer's "fingerprint." Injection of the vaccine may cause the patient's immune system to recognize and attack any cells with the specific cancer fingerprint. Ipilimumab is a drug approved by the FDA for the treatment of metastatic melanoma that boosts immune response.

Key Dates

Start date
Dec 31, 2015
Status verified
Jan 2016
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ipilimumab + HSPPC-96
    * Ipilimumab is administered intravenously at a dose of 3 mg/kg one day (a minimum of 12 hours and not more than 48 hours) before HSPPC-96 every 21-25 days for a total of 4 cycles. * HSPPC-96 is administered at a dose of 25 μg by intradermal injection always 12 - 48 hours following ipilimumab on a weekly basis for the first 4 weeks and then every 3 weeks always 12 - 48 hours after ipilimumab. * Length of Treatment: 4 cycles of ipilimumab and at least 6 cycles of HSPPC-96 up to 12 doses. * Booster doses of HSPCC-96 following 6 administrations on subsequent cycles will be administered every 21-23 days according to availability of vaccine.

Primary Outcome Measure

All enrolled patients who receive at least one dose of study drug (HSPPC-96) will be evaluated for safety. (adverse events) [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
UTHealth Memorial Hermann Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
UTHealth Memorial Hermann Cancer Center· Houston, TX

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