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Evaluation of Two Different Schedules of Palonosetron for the Prevention of Nausea and Vomiting in Patients With Metastatic Melanoma Receiving Concurrent Biochemotherapy

Phase 1/Phase 2
18 Years
65 Years
Not Enrolling

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Trial Information

Evaluation of Two Different Schedules of Palonosetron for the Prevention of Nausea and Vomiting in Patients With Metastatic Melanoma Receiving Concurrent Biochemotherapy

Palonosetron is designed to work by blocking the substance serotonin from binding to the
brain and gastrointestinal tract, which may help to decrease nausea and vomiting.

Participants in this study will be receiving biochemotherapy treatment as part of their
routine care. This treatment will include 3 chemotherapy drugs (cisplatin, vinblastine, and
DTIC) and 2 drugs that stimulate the immune system (interferon and interleukin-2 (IL-2)).
Biochemotherapy often causes nausea, vomiting, loss of appetite, and weight loss.
Palonosetron will be given on this study to try to treat the side effects of

If you agree to take part in this study, you will be randomly assigned (as in the toss of a
coin) to one of 2 treatment groups. You have an equal chance of being assigned to either

Participants in Group 1 will receive palonosetron by vein over a few minutes starting 30
minutes before receiving chemotherapy on Days 1 and 4 of therapy. Participants in Group 2
will receive palonosetron by vein over a few minutes on Days 1, 3, and 5.

All participants on this study will also receive Ativan by vein every 8 hours for 5 days.
Ativan is given for additional control of nausea and it will also help to sedate you. In
addition to palonosetron, you may be given standard anti-nausea medications such as
lorazepam or compazine if you experience intolerable nausea and vomiting while on study.

You will also be asked to fill out a Functional Living Index-Emesis (FLIE) questionnaire
every day for 7 days in a row. The questionnaire will ask about any nausea and/or vomiting
you are experiencing and the effect of the therapy on your quality of life. You will stay in
the hospital for at least 7 days while you receive treatment.

After the first course of palonosetron given with biochemotherapy, your doctor will decide
if you will receive additional courses of palonosetron or if you will be given another
anti-nausea drug.

If your doctor does decide to have you continue on palonosetron, it will be given off study.
Your participation in this study will be over after 1 course.

This is an investigational study. Palonosetron has been approved by FDA for control of
nausea and vomiting caused by chemotherapy. However, it has not been adequately evaluated
for safety and effectiveness in patients receiving high dose interleukin-2 alone or in
combination with chemotherapy. About 30 patients will take part in this study. All patients
will enrolled at M. D. Anderson.

Inclusion Criteria:

- They have non-resectable stage III or IV metastatic melanoma with measurable disease
and have agreed to be treated with biochemotherapy.

- They have Zubrod performance status of 0-1

- They have normal blood counts with a white blood count (WBC) count >/= 3,500/mm^3,
ANC >/= 1,500/mm^3 and a platelet count >/= 100,000/mm^3 and have serum creatinine
<1.5 mg/dl, and serum bilirubin level < 1.5 mg/dl, and no evidence of significant
cardiac or pulmonary dysfunction.

- They have no significant intercurrent illness such as a serious infection,
significant psychiatric illness, hypercalcemia (calcium >11 mg), gastro-intestinal
(GI) bleeding or evidence of brain metastasis.

- They have not been exposed to prior interferon, interleukin-2 or previous
chemotherapy including regional perfusion. Prior radiation therapy for metastatic
melanoma is permitted provided the patient has unirradiated metastatic sites for
response evaluation and has fully recovered from its toxicity.

- They must have been off corticosteroids for at least 2 weeks.

Exclusion Criteria:

- They are younger than 18 years or more than 65 years of age and those with an
expected survival of less than 8 weeks or a Zubrod performance status of 2, 3 or 4.

- They have received previous treatment with any prior systemic chemotherapy for
unresectable metastasis including and not limited to the following drugs: cisplatin,
vinblastine, Dacarbazine (DTIC), interferon and interleukin-2

- They have active central nervous system involvement by melanoma either as brain
metastasis, spinal cord compression, or meningeal carcinomatosis".

- They have significant cardiac illness such as symptomatic coronary artery disease or
previous history of myocardial infarction, impaired left ventricular function or
serious cardiac arrhythmias requiring therapy.

- They have significant impairment of pulmonary function on account of chronic
bronchitis or chronic obstructive pulmonary disease (COPD).

- They have symptomatic effusions on account of pleural, pericardial or peritoneal
metastasis of melanoma.

- They have history of a second malignant tumor (except for other skin cancers and in
situ carcinoma of the cervix) within the past 5 years and uncertainty about the
histologic nature of the metastatic lesions.

- They are on corticosteroids or any other type of immunosuppressive agent (e.g.,
methotrexate, chloroquine, azathioprine, cyclophosphamide).

- They are pregnant or breast feeding. Patients of childbearing potential must agree to
use an effective method of contraception.

- They have known hypersensitivity to any of the study drugs or to other selective

- They have ongoing emesis due to any organic etiology including but not limited to
central nervous system or gastrointestinal metastasis.

- They have grade 2 or higher nausea due to administration of drugs including but not
limited to narcotics.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Cumulative Participants Response to Palonosetron

Outcome Description:

Participants response measured as incidences biochemotherapy emesis and those of nausea interfering with appetite, sleep, physical activity, social life and enjoyment of life are summarized. Response evaluated during 5-day administration of biochemotherapy and the 23 subsequent days after therapy ends.

Outcome Time Frame:

7 days

Safety Issue:


Principal Investigator

Agop Y. Bedikian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2006

Completion Date:

May 2009

Related Keywords:

  • Melanoma
  • Melanoma
  • Nausea
  • Vomiting
  • Palonosetron
  • Cisplatin
  • Vinblastine
  • Loss of Appetite
  • Weight loss
  • Melanoma
  • Nausea
  • Vomiting



U.T. M.D. Anderson Cancer Center Houston, Texas  77030