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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Minor, MD, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01743157
First received: April 4, 2011
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Metastatic Melanoma
Drug: Biochemo + bevacizumab then ipilimumab
Phase 1
Phase 2

Access to an investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I-II Study of Treatment of Metastatic Melanoma Using Induction Therapy With Biochemotherapy and Bevacizumab Followed by Consolidation Therapy With Ipilimumab (BBI)

Resource links provided by NLM:


Further study details as provided by California Pacific Medical Center Research Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Determine the incidence of grade 4 bevacizumab-related toxicities and grade 3 proteinuria when bevacizumab is given with biochemotherapy to patients with metastatic melanoma for up to 3 years.


Secondary Outcome Measures:
  • 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: Secondary Objective ] [ Designated as safety issue: No ]
    Compare median and overall progression-free survival to previously published historical control group of 135 patients receiving biochemotherapy followed by pulse IL-2, and also patients in the study of Weber et al (Reference 9) of ipilimumab in previously untreated patients for up to 4 years.


Enrollment: 24
Study Start Date: December 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Biochemo + bevacizumab then ipilimumab
Bevacizumab 7.5mg/kg week 1,repeat weeks 4,7,10 (cycles 2, 3, & 4)
Other Names:
  • Avastin,
  • Temodar,
  • Platinol,
  • Velban,
  • interleukin-2,
  • Intron-A,
  • Yervoy

Detailed 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743157

Locations
United States, California
San Francisco Oncology Associates
San Francisco, California, United States, 94115
Sponsors and Collaborators
California Pacific Medical Center Research Institute
Investigators
Principal Investigator: David R Minor, MD California Pacific Medical Center
  More Information

No publications provided

Responsible Party: David Minor, MD, Medical Doctor, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01743157     History of Changes
Other Study ID Numbers: BBI Total Therapy
Study First Received: April 4, 2011
Last Updated: August 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Bevacizumab
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014