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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01409187
Recruitment Status : Withdrawn
First Posted : August 4, 2011
Last Update Posted : January 26, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Melanoma Drug: Ipilimumab Drug: Interferon Drug: Interleukin-2 (Aldesleukin) Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IPI-Biotherapy for Patients With Metastatic Melanoma Previously Treated With Cytotoxic Drugs
Study Start Date : October 2011
Estimated Primary Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Progression Free survival (PFS) [ Time Frame: Assessed at 6-months then until disease progression or death. ]
    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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01409187

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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01409187     History of Changes
Other Study ID Numbers: 2011-0074
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: January 26, 2012
Last Verified: January 2012

Keywords provided by M.D. Anderson Cancer Center:
Metastatic Melanoma
Cytotoxic Drugs
IFN Alpha-2b
Intron A
Interferon Apha-2b

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibodies, Monoclonal
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents