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

California Pacific Medical Center Research Institute

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metastatic Melanoma

Treatments: Drug: Biochemo + bevacizumab then ipilimumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01743157

BBI Total Therapy

Details and patient eligibility

About

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

Full description

A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy (Temodar,Cisplatin, Velban,IL2 and IFN)plus Bevacizumab followed by consolidation therapy with Ipilimumab (BBI)

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Stage 4 or unresectable stage 3 metastatic melanoma with or without measurable disease
2. Age 18-70 years old
3. Adequate pulmonary and cardiac function for high-dose IL-2
4. PS 0-2
5. Previous ipilimumab therapy will not exclude patients, but patients with previous ipilimumab will have separate efficacy analysis

Exclusion criteria

1. Brain metastases
2. Creatinine > 2x ULN; bilirubin > 3, WBC < 3500, Platelets < 100,000, Hgb < 9
3. Another active malignancy
4. Gastrointestinal tract metastases except rectal metastases or primary are allowable
5. Previous therapy for metastatic disease with chemotherapy of duration over 3 months or with high-dose interleukin-2
6. History of colitis or autoimmune disease such as lupus or rheumatoid arthritis
7. Bevacizumab-related contraindications: Hemoptysis or history of severe bleeding, uncontrolled hypertension, proteinuria with protein/creatinine ratio > 1, acute myocardial infarction within 6 months

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Biochemo + Bevacizumab then Ipilimumab

Experimental group

Description:

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.

Treatment:

Drug: Biochemo + bevacizumab then ipilimumab