Ipilimumab and Lenalidomide in Advanced Cancer
This study is currently recruiting participants.
Verified May 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01750983
First received: December 13, 2012
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
The goal of this clinical research study is to find the highest tolerable dose of the combination of Yervoy® (ipilimumab) with Revlimid® (lenalidomide) that can be given to patients with advanced cancer. The safety of these drugs will also be studied.
Ipilimumab is designed to increase the immune system's ability to fight cancer.
Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancers |
Drug: Ipilimumab Drug: Lenalidomide |
Phase 1 |
| 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 Trial of Ipilimumab (Anti CTLA- 4 Antibody) in Combination With Lenalidomide (IMiD) in Patients With Advanced Malignancies |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) of Ipilimumab in Combination With Lenalidomide [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Maximum tolerated dose (MTD) defined as highest dose studied in which the incidence of dose limiting toxicity (DLT) was less than 33%.
- Dose-Limiting Toxicities (DLT) of Ipilimumab in Combination With Lenalidomide [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Dose-limiting toxicity (DLT) defined as any clinically grade 3 or 4 non-hematologic toxicity as defined in NCI CTC v4.0, expected and believed to be related to study medications (except nausea and vomiting, electrolyte imbalances responsive to appropriate regimens or alopecia), any grade 4 hematologic toxicity lasting at least 3 weeks or longer (as defined by the NCI-CTC v4.0) or associated with bleeding and/or sepsis; any grade 4 nausea or vomiting > 5 days despite maximum anti-nausea regimens, and any other grade 3 non-hematologic toxicity including symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complication or abnormality not defined in NCI-CTCAE v4.0 that is attributable to the therapy.
| Estimated Enrollment: | 101 |
| Study Start Date: | March 2013 |
| Estimated Primary Completion Date: | March 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ipilimumab + Lenalidomide
Dose Escalation Group Ipilimumab Starting Dose: 1.5 mg by vein over 90 minutes on Day 1 of each 28 day cycle. Dose Escalation Group Lenalidomide Starting Dose: 10 mg by mouth on Days 1-21 of each 28 day cycle. Dose Expansion Group Starting Dose for Ipilimumab and Lenalidomide: Maximum tolerated dose (MTD) from Dose Escalation Groups. |
Drug: Ipilimumab
Dose Escalation Group Starting Dose: 1.5 mg by vein over 90 minutes on Day 1 of each 28 day cycle. Dose Expansion Group Starting Dose for Ipilimumab: Maximum tolerated dose (MTD) from Dose Escalation Group. Other Names:
Drug: Lenalidomide
Dose Escalation Group Starting Dose: 10 mg by mouth on Days 1-21 of each 28 day cycle. Dose Expansion Group Starting Dose for Lenalidomide: Maximum tolerated dose (MTD) from Dose Escalation Group. Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with advanced or metastatic cancers with no available standard therapy are eligible to enter the Phase 1 portion of this study.
- Patients must be >/= 18 years.
- Patients must be >/= 3 weeks beyond treatment with a cytotoxic chemotherapy regimen, or therapeutic radiation, or major surgery. A confirmation (written or verbal) that there is no risk of surgical complications from a patient's surgeon has to be obtained prior to starting therapy in patients with a history of major surgery within past 6 weeks. Patients may have received palliative localized radiation immediately before or during treatment provided that radiation is not delivered to the only site of disease being treated under this protocol. For biologic/targeted agents patients must be >/= 5 half-lives or >/= 3 weeks form the last dose (whichever comes first).
- ECOG performance status </= 2.
- Patients must have adequate organ and marrow function defined as: absolute neutrophil count >/= 1,000/mL platelets >/=75,000/mL; CrCl >/=60mL/min by Cockcroft-Gault calculation; total bilirubin </= 2x ULN; ALT(SGPT) </= 5X ULN; willingness to participate in the RevAssist® program. Females: two effective contraceptive methods should be used during therapy, during therapy interruptions, and for at least 4 weeks after completing therapy. Males: must always use a latex condom during any sexual contact with females of childbearing potential, even if they have undergone a successful vasectomy.
- Patients must be able to understand and be willing to sign a written informed consent document.
Exclusion Criteria:
- Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
- Pregnant or lactating women.
- History of hypersensitivity to ipilimumab.
- History of hypersensitivity to lenalidomide.
- Patients unwilling or unable to sign informed consent document.
- Patients on hemodialysis.
- History of organ transplantation.
- History of autoimmune disease, including inflammatory bowel disease.
- History of severe motor or sensory neuropathy, or any other autoimmune disorder which is deemed to be significant.
- Patients with a prior history of Grade 4 rash associated with thalidomide treatment.
- History of Angioedema.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750983
Contacts
| Contact: Filip Janku, MD, PHD | 713-563-1930 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Filip Janku, MD, PHD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01750983 History of Changes |
| Other Study ID Numbers: | 2012-0795 |
| Study First Received: | December 13, 2012 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Advanced Cancers Advanced Malignancies Metastatic cancers Ipilimumab Yervoy |
BMS-734016 MDX010 Lenalidomide CC-5013 Revlimid |
Additional relevant MeSH terms:
|
Neoplasms Lenalidomide Thalidomide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013