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RADVAX: A Stratified Phase I/II Dose Escalation Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Metastatic Melanoma

This study is currently recruiting participants.
Verified February 2013 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01497808
First received: December 13, 2011
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

Stratified phase I/II study of escalating fractions of stereotactic body radiotherapy combined with immunotherapy for previously untreated/previously treated metastatic melanoma patients. Phase I is stratified by site: bone/lung versus liver/subcutaneous. Phase II is stratified by prior treatment: previously untreated versus previously treated. In phase II, 14 patients will be treated at the maximum tolerated dose (MTD) in each stratum of which phase I patients treated at the site specific MTD will be included.


Condition Intervention Phase
Metastatic Melanoma
 Drug: Ipilimumab
Radiation: Stereotactic Body Radiation Therapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: RADVAX: A Stratified Phase I/II Dose Escalation Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Metastatic Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Ipilimumab
U.S. FDA Resources

Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Dose-limiting toxicity (DLT) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Participants with adverse events [ Time Frame: after 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: December 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 1 Drug: Ipilimumab Radiation: Stereotactic Body Radiation Therapy
Experimental: Phase 2 Drug: Ipilimumab Radiation: Stereotactic Body Radiation Therapy

Detailed Description:

This is a stratified phase I/II study of escalating fractions of stereotactic body radiotherapy (SBRT) combined with immunotherapy with Ipilimumab for previously untreated or previously treated metastatic melanoma patients who are aged 18 years or older. Phase I is stratified by site: bone or lung versus liver or subcutaneous (s.c.) Six patients will be enrolled per dose cohort. Phase II is stratified by prior treatment:previously untreated for metastatic disease versus previously treated for metastatic disease. In phase II, 14 patients will be treated at the MTD (maximum tolerated dose) in each stratum of which phase I patients treated at the site specific MTD will be included. Descriptive statistics will be generated for both phases of the study.

  Eligibility

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

Inclusion Criteria:

  • Patients aged 18 years and older.
  • Histologically confirmed diagnosis of melanoma
  • Previously treated or previously untreated stage IV melanoma by AJCC staging criteria
  • Presence of an index lesion between 1 cm and 5 cm.
  • EGOC performance status 0 to 1
  • Signed informed consent document.
  • Adequate renal, hepatic, and hematologic indices for ipilimumab therapy
  • Ability to tolerate stereotactic body radiation therapy (e.g. lie flat and hold position for treatment)

Exclusion Criteria:

  • Prior systemic therapy within 28 days of study enrollment
  • Clinical contraindication to stereotactic body radiotherapy (e.g.active systemic sclerosis, active inflammatory bowel disease if bowel is within target field, etc)
  • Previous treatment with antiCTLA-4 antibody or cancer vaccine
  • Presence or history of central nervous system metastasis (including brain)
  • Long-term use of systemic corticosteroids
  • Prior RT within 2 months of study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497808

Contacts
Contact: Ramesh Rengan, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the Universirty of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ramesh Rengan, MD     855-216-0098     PennCancerTrials@emergingmed.com    
Principal Investigator: Ramesh Rengan, MD            
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Ramesh Rengan, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01497808     History of Changes
Other Study ID Numbers: UPCC 06611
Study First Received: December 13, 2011
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
previously untreated
previously treated
bone, lung, liver or subcutaneous involvement
nodal involvement
without evidence of brain involvement

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

ClinicalTrials.gov processed this record on May 22, 2013