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

NCT ID: NCT01743157

Last Updated: 2013-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-05-31

Brief Summary

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

Detailed Description

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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)

Conditions

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Metastatic Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Biochemo + bevacizumab then ipilimumab

Intervention Type DRUG

Bevacizumab 7.5mg/kg week 1,repeat weeks 4,7,10 (cycles 2, 3, \& 4)

Interventions

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Biochemo + bevacizumab then ipilimumab

Bevacizumab 7.5mg/kg week 1,repeat weeks 4,7,10 (cycles 2, 3, \& 4)

Intervention Type DRUG

Other Intervention Names

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Avastin, Temodar, Platinol, Velban, interleukin-2, Intron-A, Yervoy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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California Pacific Medical Center Research Institute

OTHER

Sponsor Role lead

Responsible Party

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David Minor, MD

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David R Minor, MD

Role: PRINCIPAL_INVESTIGATOR

California Pacific Medical Center

Locations

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San Francisco Oncology Associates

San Francisco, California, United States

Site Status

Countries

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United States

References

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3. Minor DR, Wang W, Kashani-Sabet: Concurrent bevacizumab (BEV) with biochemotherapy (BIO) followed by ipilimumab for advanced melanoma: a phase I-II trial. J Clin Onc 2013 (suppl; abstr e200001)

Reference Type RESULT

Other Identifiers

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BBI Total Therapy

Identifier Type: -

Identifier Source: org_study_id