MDACC Study Summary 2007-0361

Study Summary
No. 2007-0361:.......Advanced Cancers; Melanoma......Agop Y. Bedikian......Melanoma Medical Oncology

Study Summary Title



Study Summary Number:	2007-0361

Study Title:	A multicenter, randomized, double-blind study of dacarbazine with or without Genasense® in chemotherapy naļve subjects with advanced melanoma and low LDH (The AGENDA Trial)

Physician

New Patient Referral



Name:	Agop Y. Bedikian	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Melanoma Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2921 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers Melanoma	Supported By:	Genta Inc

Phase of Study:	Phase III	Return Visit:	3 weeks

Treatment Agents:	Dacarbazine Genasense	Home Care:	N/A

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to compare the effectiveness of receiving dacarbazine plus genasense (oblimersen) treatment to receiving dacarbazine plus a placebo (a liquid that looks like the study drug but has no active ingredients) in patients with previously untreated advanced melanoma.

Study Objectives / Outcomes

Primary objective

The primary objective of this study is to compare progression-free survival and overall survival in the
dacarbazine plus Genasense treatment group and the dacarbazine plus placebo treatment group.

Secondary objectives

The secondary objectives of this study are to compare the 2 treatment groups with respect to the percentages of subjects with response and durable response, duration of response, and the safety of the 2 treatment regimens.

Study Status Information



Study Activation / Registration Date:	07/30/2007

IRB Review and Approval Date:	07/30/2007

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	300

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) Histologically confirmed diagnosis of melanoma.

2) Progressive disease that is not surgically resectable, or metastatic Stage IV disease

3) LDH </= 0.8 x ULN

4) Chemotherapy naļve. Note: Prior immunotherapy, radiotherapy, or cytokine, biologic, or vaccine therapy is permitted.

5) Measurable disease defined as at least 1 tumor lesion that can be accurately and serially measured in at least 1 dimension (longest diameter to be recorded) and is >/= 20 mm with conventional techniques and >/= 10 mm with spiral CT, based on Response Evaluation Criteria in Solid Tumors (RECIST).

6) Lesions that are considered nonmeasurable include: (1) Bone Lesions, (2) Ascites and pleural/pericardial effusions, (3) Lymphangitis cutis/pulmonis, (4) Abdominal masses not confirmed and not followed by imaging studies, (5) Cystic Lesions, (6) Tumors treated by irradiation or intra-tumor injection therapy without progression in that area or measurable disease outside that area.

7) ECOG performance status </= 1.

8) At least 4 weeks and recovery from effects of prior surgery or other therapy, including immunotherapy, radiotherapy, or cytokine, biologic, or vaccine therapy.

9) Adequate organ function, defined as: (a) Absolute neutrophil count (ANC) >/= 1500/mm^3, (b) Platelet count >/= 100,000/mm^3, (c) Hemoglobin >= 11 g/dL without need for hematopoietic growth factor or transfusion support, (d) Serum creatinine </= 1.5 x ULN or 24-hour creatinine clearance >/= 50 mL/min.

10) (continued from #10): (e) Serum bilirubin </= 1.5 x ULN, (f) Aspartate aminotransferase (AST) </= 2.5 x ULN, (g) Alanine aminotransferase (ALT) </= 2.5 x ULN, (h) Alkaline phosphatase </=2.5 x ULN, (i) Serum albumin >/= 3.0 g/dL, (j) Prothrombin time (PT) </= 1.5 x ULN (or international normalized ratio [INR] </= 1.3), (k) Partial thromboplastin time (PTT) </= 1.5 x ULN.

11) At least 18 years of age.

12) Venous access adequate to maintain a 5-day continuous intravenous infusion.

13) Ability to maintain an ambulatory infusion pump

14) In women of childbearing potential (that is, all women except for those who are post menopause for > 1 year or who have a history of hysterectomy or surgical sterilization), a negative serum pregnancy test within 7 days prior to randomization

15) In subjects of childbearing potential (that is, all men and all women excluding women who are post menopause for > 1 year or who have a history of hysterectomy or surgical sterilization), agreement to use a highly effective form of contraception (ie, one that has a failure rate of < 1%) throughout the treatment phase of the study

Exclusion Criteria:

1) Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense treatment.

2) Need for other anticancer treatment (such as chemotherapy, radiation, or biologic or investigational therapies) while receiving protocol therapy in this study.

3) Primary ocular or mucosal melanoma.

4) Bone-only metastatic disease.

5) History or presence of brain metastasis or leptomeningeal disease.

6) History of second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 or more years).

7) Significant medical disease other than cancer, such as: uncontrolled congestive heart failure; active symptoms of coronary artery disease (defined as uncontrolled arrhythmias or recurrent chest pain despite prophylactic medication); New York Heart Association Class III or IV disease; cardiovascular signs and symptoms >/= Grade 2 by common toxicity criteria (CTC) during the 4-week period prior to initiation of protocol therapy;

8) (continued from #7): uncontrolled seizure disorder; history of chronic hepatitis or cirrhosis; active infection; uncontrolled diabetes mellitus; requirement for chronic corticosteroid treatment with an average dose >/= 20 mg/day of prednisone (or equivalent); requirement for concurrent immunosuppressive drug(s); active autoimmune disease.

9) Organ allograft.

10) Known human immunodeficiency virus infection.

11) Pregnancy or lactation

12) Known hypersensitivity to dacarbazine or phosphorothioate-containing oligonucleotides.

13) Use of any experimental therapy within 3 weeks prior to screening evaluations.

Links

Registration Number: NCT00518895
Study Information on Clinical Trials Registry (clinicaltrials.gov)