Phase II Trial of Ontak With Metastatic Melanoma

NCT00299689 | Completed Phase 2 Results DMC

• 1 other identifier: 076.06
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether ONTAK is an effective treatment in patients with Stage IV Melanoma

Conditions

Malignant Melanoma

Keywords

Melanoma; Metastatic; Stage IV; Ontak

Outcome Measures

Primary Outcomes (1)

• Positive Response Defined as Clinical Complete Response, Partial Response or Stable Disease (Persisting for at Least 4 Weeks) as Measure by Modified RECIST Criteria

  2 weeks after completion of second cycle

Secondary Outcomes (1)

• Overall Survival

  All cause mortality

Study Arms (1)

Intervention

EXPERIMENTAL

Single-arm: Ontak

Drug: Denileukin diftitox

Interventions

Denileukin diftitox DRUG

12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles.

Also known as: ONTAK

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Only patients with distant metastases from cutaneous or mucosal melanoma or melanoma of unknown primary are eligible for this study. * Only patients with distant metastases from cutaneous or mucosal melanoma or melanoma of unknown primary are eligible for this study. All patients must fulfill the following criteria: * Primary tumor must be documented by histopathologic analysis * Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria (Appendix). Cutaneous lesions measuring at least 1 cm will be considered measurable. Measurements must be documented by radiologic examinations (CT scan, PET scan). * Disease recurrences occurring greater than five years after the original diagnosis must be biopsy proven. * Patients with lymph node metastases in multiple lymph node beds who are not amenable to surgical resection will be included in this study. Those patients with involvement of a single lymph node bed are not eligible. * Liver Function: Patients must have adequate hepatic function documented by a serum bilirubin \< 1.5 x the institutional upper limit of normal and liver enzymes (SGOT or SGPT and LDH and alkaline phosphatase) \<2X the institutional upper limit of normal within 28 days prior to registration. * Bone Marrow Function: Patients must have an absolute granulocyte count \> 1,500/ul and platelet count \> 100,000/ul obtained within 14 days prior to registration. * Renal Function: Patients must have either a serum creatinine \<1.5 mg/dl or a calculated creatinine clearance \> 75 cc/min using the following formula: * Estimated Creatinine Clearance = (140-age) X WT(kg) X 0.85 (if female 0.72) X creatinine (mg/dl) These tests must have been performed within 28 days prior to registration. * Patients must have a MRI of the head performed within four weeks prior to registration. * Cardiac Function: Patients must not have a history of ventricular fibrillation, sinus node or AV nodal disease, Wolff Parkinson White Syndrome, evidence of congestive heart failure, symptoms of coronary artery disease, serious cardiac arrhythmia, or evidence of prior myocardial infarction on EKG. The qualifying EKG must have been performed prior to study registration, but no earlier than 28 days prior to the definitive surgery. A normal cardiac stress test within 182 days prior to randomization is required for all patients over 50 years old or those with abnormal EKG or any history of cardiac disease. * Patients must not have evidence of symptomatic pulmonary disease. PFT's within 182 days prior to registration showing a FEV1 \> 2.0 liters or \>75% of predicted are required for patients over 50 or with history of pulmonary symptoms. * Patients with known autoimmune disorders, conditions of immunosuppression or treatment with systemic corticosteroids are not eligible for this study. Patients with known AIDS or HIV-1 associated complex or known to be HIV antibody seropositive are not eligible for this study. * All patients must be 18 years of age or older. * All patients must have a Zubrod Performance Status of 0 -1 * Patients must not be planning to receive concomitant other biologic therapy, radiation therapy, hormonal therapy, other chemotherapy, surgery, or other therapy while on this protocol. * Pregnant or nursing women may not participate in this trial. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. A beta HCG pregnancy test is required within 14 days of registration for women of childbearing potential. * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• James Graham Brown Cancer Center: lead
• University of Louisville: collaborator

Study Sites (1)

James Graham Brown Cancer Center, Univ. of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Publications (2)

• Telang S, Rasku MA, Clem AL, Carter K, Klarer AC, Badger WR, Milam RA, Rai SN, Pan J, Gragg H, Clem BF, McMasters KM, Miller DM, Chesney J. Phase II trial of the regulatory T cell-depleting agent, denileukin diftitox, in patients with unresectable stage IV melanoma. BMC Cancer. 2011 Dec 13;11:515. doi: 10.1186/1471-2407-11-515.

  PMID: 22165955 DERIVED

• Rasku MA, Clem AL, Telang S, Taft B, Gettings K, Gragg H, Cramer D, Lear SC, McMasters KM, Miller DM, Chesney J. Transient T cell depletion causes regression of melanoma metastases. J Transl Med. 2008 Mar 11;6:12. doi: 10.1186/1479-5876-6-12.

  PMID: 18334033 DERIVED

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

Interventions

denileukin diftitox

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Jason Chesney
• Organization: James Graham Brown Cancer Center, University of Louisville

jaches03@exchange.louisville.edu

502/852-3679

Study Officials

• Jason Chesney, MD, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2006
• First Posted: March 7, 2006
• Study Start: March 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: September 5, 2014
• Results First Posted: September 5, 2014

Record last verified: 2013-05

Locations

US (1)