MDACC Study Summary 2006-0750 (Archived)

Study Summary
No. 2006-0750:.......Advanced Cancers......Sriram Yennurajalingam......Palliative Care & Rehabilitation Medicine

Study Summary Title



Study Summary Number:	2006-0750

Study Title:	A Pilot Clinical Trial of Lenalidomide (Revlimid®) for the treatment of refractory cancer pain

Physician

New Patient Referral



Name:	Sriram Yennurajalingam	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Palliative Care & Rehabilitation Medicine	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6085 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers	Supported By:	Clegene Corporation

Phase of Study:	Phase II	Return Visit:	Up to FIVE (5): Day 15, day 29, day 43 and if on the extension phase day 57 (all dates are +/- 3 days) and at the end of followup phase which is day 71 or day 85 in patients who participate in the extension phase.

Treatment Agents:	Lenalidomide	Home Care:	Blood work and Nursing Telephone Evaluation on days 8, 22 and 36 (+/- 3 days) The nursing telephone evaluation (with ESAS) has been validated and will obtain pain intensity score measurements more frequently than by patient visit alone.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn if lenalidomide can help to treat uncontrolled pain caused by advanced cancer.

Study Objectives / Outcomes

Primary:
1.1. Determine efficacy of Lenolidomide for the treatment of refractory cancer pain, as measured by the change on Edmonton symptom assessment scale (ESAS).

Secondary:
2.1. To determine the effect of Lenolidomide on fatigue, sleep, depressed mood, nausea and appetite/anorexia.
2.2. Determine changes in serum levels of inflammatory cytokines (IL-1beta, IL-6, TNF-alpha, IFN-alpha and IFN-gamma, and C-reactive protein) before and after treatment with Lenolidomide.
2.3. Effect of Lenolidomide on T-cell subsets especially T-regulatory cells
2.4. Effect of Lenolidomide on the expression of costimulatory receptors, CD80, CD86, and CD40, on myeloid and plasmacytoid dendritic cells
2.5. Safety (type, frequency, severity, and relationship of adverse events to study treatment)

Study Status Information



Study Activation / Registration Date:	05/22/2008

IRB Review and Approval Date:	11/15/2007

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients with advanced cancer with a diagnosis of refractory cancer pain (Refractory cancer pain is defined for research purposes as the pain secondary to cancer that is refractory to strong opioids as determined by the persistence of pain despite atleast 2 or more opioid escalation and/ or opioid rotations for a given pain syndrome).

2) Pain intensity score of 5 or greater on Edmonton Symptom Assessment scale.

3) Understand and voluntarily sign an informed consent form.

4) Age >/=18 years at the time of signing the informed consent form.

5) Able to adhere to the study visit schedule and other protocol requirements.

6) Patients who are receiving chemotherapy are eligible for study if approved by primary oncologist. The PI or enrolling physician will obtain and document approval from the primary oncologist in the patient's study documents.

7) Will consent to the use of asprin (81 or 325 mg) or Low molecular weight heparin (if intolerant to to asprin)

8) Laboratory test results within these ranges within the past 14 days: Absolute neutrophil count >/= 1.5 x 10^9/L , Platelet count >/= 100 x 10^9/L, Serum creatinine </= 2.0 mg/dL, Total bilirubin </=1.5 mg/dL, and AST (SGOT) and ALT (SGPT) </=2 x ULN or </= 5 x ULN if hepatic metastases are present.

9) All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.

10) Females of childbearing potential (FCBP). A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

11) FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 to 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide.

12) FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix : Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.

13) Patients who have been previously exposed to thalidomide or lenalidomide. These patients will require a washout period of 1 month prior to initiating the trial

14) Patients with lymphoma and myeloma may be included in this study.

Exclusion Criteria:

1) Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.

2) Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).

3) Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

4) Use of any other experimental drug or therapy within 28 days of baseline.

5) Known hypersensitivity to thalidomide.

6) A history of development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.

7) Concomitant use of sargramostim (GM-CSF), including radiation, thalidomide, or other investigational agents is not permitted while subjects are receiving study drug during the treatment portion of the study.

8) Known positive for HIV or infectious hepatitis, type A, B or C.

9) History of alcohol abuse as determined by the CAGE questionnaire (> / = 2/4).

10) Individual with clinically evident impaired cognition.

11) Patient with a history of psychiatric diagnosis of depression or clinical diagnosis of depression as determined by the treating physician or Hospital Anxiety Depression Scale total score of 13 or greater.

12) All major surgeries such as thoracotomy etc., that requires wound healing within last 2 weeks

Links

Registration Number: NCT00684242
Study Information on Clinical Trials Registry (clinicaltrials.gov)