Biochemotherapy and Bevacizumab Followed by Consolidation Therapy With Ipilimumab for Metastatic Melanoma

Part of paid clinical trials in San Francisco, California.

Sponsor
California Pacific Medical Center Research Institute
Study ID
NCT01743157
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy plus Bevacizumab followed by consolidation therapy with Ipilimumab (BBI).

Key Dates

Start date
Dec 31, 2010
Status verified
Aug 2013
Primary completion
May 31, 2013
Completion
May 31, 2013

Study Design

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

Arms

  • Experimental: Biochemo + Bevacizumab then Ipilimumab
    Single arm: Biochemotherapy with 4 cycles at 3 week intervals of Temozolamide 150mg/m2 x4, cisplatin 20mg/m2 x 4, vinblastine 1.2mg/m2 x 4, bevacizumab 7.5-15 mg/kg x 1, interferon 5mg/m2 x5 and aldesleukin 36,18,9, % 9 miu/day over 4 days each cycle; then ipilimumab 3mg/kg q 21 days x 4, then q 3 months x 8 for total 3 years.

Primary Outcome Measure

A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy and Bevacizumab followed by consolidation therapy with Ipilimumab (BBI) [ Time Frame: Primary Objective ]

Locations (1)

FacilityCityStateZIPSite coordinators
San Francisco Oncology AssociatesSan FranciscoCalifornia94115-

Find similar trials in San Francisco, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
San Francisco Oncology Associates· San Francisco, CA

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