Overview

This trial is active, not recruiting.

Condition melanoma
Treatments abi-007, ipilimumab, phone call
Phase phase 2
Target CTLA-4
Sponsor M.D. Anderson Cancer Center
Collaborator Celgene
Start date April 2013
End date April 2018
Trial size 21 participants
Trial identifier NCT01827111, 2011-1157, NCI-2014-01238

Summary

The goal of this clinical research study is to learn if the combination of ipilimumab and ABI-007 (abraxane) can help to control metastatic melanoma. The safety of this drug combination will also be studied.

Ipilimumab is designed to increase the immune system's ability to fight cancer.

Abraxane is designed to stop cancer cells from making new DNA (the genetic material of cells). This may stop the cancer cells from dividing into new cells.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. Ipilimumab 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses. Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes.
abi-007 Nab-paclitaxel
Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. The cycle length for ABI-007 is 28 days.
ipilimumab Yervoy
3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses.
phone call
Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes.

Primary Outcomes

Measure
Progression-Free Survival (PFS)
time frame: 6 months

Eligibility Criteria

Male or female participants from 12 years up to 70 years old.

Inclusion Criteria: 1. Patients with histologically documented diagnosis of advanced stage IV or unresectable stage III mucosal or cutaneous melanoma are eligible. 2. They must 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. Patients should not have been previously treated with cytotoxic drugs and immunotherapeutic agents for unresectable Stage III or Stage IV disease. Prior Ipilimumab in metastatic setting is not allowed. Prior therapy may include one line of targeted therapy for metastatic disease ie BRAF or MEK inhibitor. At least 3 weeks should have passed since the last dose of prior adjuvant interferon therapy and prior targeted therapies, and all previous therapy related toxicities should have resolved before starting study treatment. Prior adjuvant interferon is permitted. Prior cytotoxic therapy in adjuvant or metastatic setting is not allowed. Prior Ipilimumab in adjuvant setting is not allowed. Prior adjuvant therapy with targeted therapy including but not limited to B-RAF, MEK inhibitors etc. is allowed. Prior palliative 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 12 years of age and 70 years of age with an ECOG performance status of 0 or 1 will be eligible 5. They should have normal blood counts with a white blood cell 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, Hemoglobin > 9.0 g/dL 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 1.5 mg/dl, AST and ALT

Additional Information

Official title Phase II Study of Abraxane Plus Ipilimumab in Patients With Metastatic Melanoma
Principal investigator Adi Diab, MD
Description Study Drug Administration: If you are found to be eligible to take part in this study, you will receive ABI-007 by vein over about 30 minutes on Days 1, 8, and 15 of each 28-day cycle. During the first 3 months that you receive abraxane, you will also receive ipilimumab. You will receive ipilimumab by vein over about 90 minutes. You will receive it 4 times, each time about 3 weeks apart. You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks. Study Tests: Every week, blood (about 1 teaspoon) will be drawn for routine tests. Before each cycle of abraxane: - Your performance status will be recorded. - You will have a physical exam, including measurement of your weight and vital signs. - Blood (about 1 teaspoon) will be drawn for routine tests. - Blood (about 1 teaspoon) will be drawn for tests of the immune system (first 3 cycles only). - You will be asked about any other drugs you may be taking and about any side effects you may be having. - If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test. Every 8 weeks (+/- 7 days), you will have a chest x-ray and CT scans or MRI scans performed to check the status of the disease. Length of Study: You may receive ipilimumab for up to 3 months. You may continue taking abraxane for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur. If you stop receiving the study drugs for any reason, you will have an End-of-Treatment Visit. End-of-Treatment Visit: Within 14 days after you stop study treatment, you will come into the clinic for the End-of-Treatment Visit. At this visit, the following tests will be performed: - You will have a physical exam, including measurement of your vital signs and weight. - You will be asked about any other drugs you may be taking and any side effects you may be having. - Blood (about 2 tablespoons) will be drawn for routine tests. - If the study doctor thinks it is in your best interest, you will have a CT scan or MRI scan to check for side effects. Every 2 months for 6 months, then every 3 months for up to 2 years, you will also be contacted by telephone or during a routine clinic visit to see how you are doing. If you are called, each call should last about 5 minutes. This is an investigational study. Ipilimumab is FDA approved and commercially available for the treatment of metastatic melanoma. abraxane is FDA approved and commercially available for the treatment of metastatic breast cancer. It is investigational to use abraxane, either alone or in combination with ipilimumab, for the treatment of metastatic melanoma. Up to 64 patients will take part in this study. All will be enrolled at MD Anderson.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.