IPI-Biotherapy for Patients Previously Treated With Cytotoxic Drugs With Metastatic Melanoma

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01409187
First received: August 2, 2011
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of the drug Yervoy (ipilimumab) that can be given with the drugs Intron-A (interferon alfa-2b) and Proleukin (aldesleukin, IL-2) to patients with metastatic melanoma. The safety of this combination will also be studied in Phase I. The goal of Phase II is to learn if this combination can help to control metastatic melanoma.

Ipilimumab, interferon alfa-2b, and aldesleukin are designed to block the activity of cells that decrease the immune system's ability to fight cancer.


Condition Intervention Phase
Melanoma
Drug: Ipilimumab
Drug: Interferon
Drug: Interleukin-2 (Aldesleukin)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IPI-Biotherapy for Patients With Metastatic Melanoma Previously Treated With Cytotoxic Drugs

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Progression Free survival (PFS) [ Time Frame: Assessed at 6-months then until disease progression or death. ] [ Designated as safety issue: No ]
    Progression-free survival determined from the start of the study until disease progression or death, whichever is first and estimated using the method of Kaplan-Meier.


Enrollment: 0
Study Start Date: October 2011
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab + Interferon + Interleukin-2
Ipilimumab starting dose 2 mg/kg intravenous (IV) day 1 only; IFN alfa-2b at 5 million U/m2 subcutaneously daily for 5 days starting day 1; IL-2 at 9 million IU/m^2 daily IV continuous infusion for 4 days on days 2-5.
Drug: Ipilimumab
Starting dose 2 mg/kg by vein on day 1 of each of the four 3-week cycles (Phase II is maximum tolerated dose (MTD) from Phase I). During Consolidation and Maintenance phases one dose every 12 weeks.
Other Names:
  • Yervoy
  • BMS-734016
  • MDX010
Drug: Interferon
5 million U/m2 subcutaneously daily for 5 days starting day 1 of each Induction and Consolidation cycle.
Other Names:
  • IFN Alpha-2b
  • Intron A
  • Interferon Alpha-2b
Drug: Interleukin-2 (Aldesleukin)
9 million IU/m^2 daily by vein by continuous infusion for 4 days (total of 96 hours, days 2-5) starting day 2 of each Induction and Consolidation cycle.
Other Names:
  • IL-2
  • Aldesleukin
  • Proleukin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically documented diagnosis of advanced stage IV or unresectable stage III melanoma are eligible.
  2. They should have recurrent melanoma with measurable or evaluable sites of disease, 1.0 cm or larger, in order to assess the response to treatment by the immune-related response criteria (irRC).
  3. Phase I: Patients with prior therapy who do not have alternative treatment of higher priority will be eligible. Phase II: the patient may have been treated with cytotoxic drugs or targeted therapies but not with IL-2, interferon and anti-CTLA4 drugs for metastatic disease. Adjuvant ipilimumab will not be permitted. Only adjuvant interferon will be permitted. Prior radiation therapy for metastatic melanoma is permitted provided the patient has unirradiated metastatic sites for response evaluation and has fully recovered from its toxicity.
  4. Patients between 18 years of age and 65 years of age with an ECOG performance status of 0, 1 or 2 will be eligible.
  5. They should have normal blood counts with a white blood count (WBC) count of more than or equal to 3000/mm^3 an absolute neutrophil count of more than or equal to 1500/mm^3 and a platelet count of more than 100,000/mm^3 and have no impairment of renal function (serum creatinine less than 1.1 mg/dl for females and less than 1.4 mg/dl for males), hepatic function (serum bilirubin level of less than 1.2 mg/dl) and no evidence of significant cardiac or pulmonary dysfunction.
  6. They should have no significant intercurrent illness such as an active infection associated with fever lasting more than 24 hours requiring antibiotics, uncontrolled psychiatric illness, hypercalcemia (calcium greater than 11 mg), or active gastrointestinal (GI) bleeding.
  7. Females of child-bearing potential (non-childbearing is defined as greater than one year post-menopausal or surgically sterilized) must use acceptable contraceptive methods( abstinence, intrauterine device, oral contraceptive or double barrier devices) and must have a negative serum or urine pregnancy test within 14 days prior to beginning treatment on this trial. Sexually active men must also use acceptable contraceptive methods for the duration of time on study.

Exclusion Criteria:

  1. Patients with bone metastases only.
  2. Patients with brain metastases unless all of their metastatic brain lesions have been resected or treated with stereotactic radiotherapy with gamma rays and they are off corticosteroids. Patient should not have significant brain edema. Patients with spinal cord compression and leptomeningeal disease. No major surgery or radiation therapy within 21 days before starting treatment.
  3. Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function (Ejection Fraction less than 50%) on account of any organic disease such as hypertension or valvular heart disease or serious cardiac arrhythmia requiring therapy. Patients will be evaluated by the investigator or his designee.
  4. Patients with significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD) which has resulted in impairment of vital capacity of FEV1 to less than 65% of predicted normal values.
  5. Patients with symptomatic effusions on account of pleural, pericardial or peritoneal metastases of melanoma.
  6. Patients who are unable to return for follow-up visits as required by this study.
  7. Patients with a history of second malignant tumor, other than the common skin cancers - basal and squamous carcinomas, within the past 3 years and uncertainty about the histological nature of the metastatic lesions. Cases with other types of malignancies should be reviewed and decided by the Principal Investigator (PI) of the study.
  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: NCT01409187

Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Agop Y. Bedikian, MD,BS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01409187     History of Changes
Other Study ID Numbers: 2011-0074
Study First Received: August 2, 2011
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Melanoma
Metastatic Melanoma
Cytotoxic Drugs
IPI-Biotherapy
Ipilimumab
Yervoy
BMS-734016
MDX010
Interferon
IFN Alpha-2b
Intron A
Interferon Apha-2b
Interleukin-2
IL-2
Aldesleukin
Proleukin

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Aldesleukin
Interferon-alpha
Interferons
Interleukin-2
Analgesics
Analgesics, Non-Narcotic
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antineoplastic Agents
Antiviral Agents
Central Nervous System Agents
Immunologic Factors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014