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Phase II Trial of ONTAK With Metastatic Melanoma

Phase 2
18 Years
Not Enrolling
Malignant Melanoma

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Trial Information

Phase II Trial of ONTAK With Metastatic Melanoma

This is a Phase II clinical trial to determine whether administration of ONTAK will result
in a significant response rate in patients with metastatic melanoma.

Although the development of effective immunotherapy and the characterization of multiagent
chemotherapy regimens have substantially improved in the treatment of metastatic malignant
melanoma, the overall results remain dismal with a 6% five year survival rate for stage IV
disease. Of the common adult-onset cancers, melanoma is widely held to be the most amenable
to immunological intervention.

The primary objective of this study is to determine the response rate and the overall
survival of patients with metastatic malignant melanoma treated with two regimens of ONTAK.

Inclusion Criteria

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

- Patients must have a MRI of the head performed within four weeks prior to

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Positive response defined as Clinical Complete Response, Partial Response or Stable disease (persisting for at least 4 weeks) as measure by modified RECIST criteria

Outcome Time Frame:

2 weeks after completion of second cycle

Safety Issue:


Principal Investigator

Jason Chesney, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Louisville


United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

January 2010

Related Keywords:

  • Malignant Melanoma
  • Melanoma
  • Metastatic
  • Stage IV
  • Ontak
  • Melanoma



James Graham Brown Cancer Center, Univ. of Louisville Louisville, Kentucky  40202