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Evaluation of Disulfiram Plus Arsenic Trioxide In Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy (Phase 1b)


Phase 1
18 Years
N/A
Not Enrolling
Both
Metastatic Melanoma

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Trial Information

Evaluation of Disulfiram Plus Arsenic Trioxide In Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy (Phase 1b)


PRIMARY OBJECTIVES:

I. Evaluate the tolerability of disulfiram and arsenic trioxide administration as a
therapeutic combination. (Phase IB)

SECONDARY OBJECTIVES:

l. Determine the response rate (complete and partial responses) and time to progression of
previously treated patients with metastatic malignant melanoma when treated with disulfiram
plus Arsenic Trioxide. (Phase II)

OUTLINE: This is a dose-escalation study of arsenic trioxide.

Patients receive disulfiram orally (PO) twice daily and arsenic trioxide intravenously (IV)
over 1-2 hours on Monday through Friday, alternating two weeks on treatment followed by two
weeks off treatment. Courses repeat every 12 weeks in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months thereafter.


Inclusion Criteria:



- Subjects must have bidimensionally measurable disease. All measurable lesions must be
assessed (by physical examination, CT scan, radionuclide scan or plain X-ray) within
28 days prior to registration. Non-measurable sites must be assessed within 42 days
prior to registration. The subject's disease status must be completely assessed and
reported.

- All subjects must undergo a CT of abdomen and chest within 28 days prior to
registration.

- All subjects must undergo either a CT or MRI of the brain within 28 days of
registration. Subjects with asymptomatic brain metastasis are eligible for this
protocol but their metastasis must be clinically stable and asymptomatic. Subjects
with Central Nervous System (CNS) metastasis must have been evaluated by neurosurgery
prior to entry to confirm that they are a candidate for this trial. Treatment of
symptomatic CNS metastasis that is required before protocol entry.

- Subjects must have progressed based on Response Evaluation Criteria in Solid Tumors
(RECIST) criteria after at least one prior systemic therapy (chemotherapy,
biologic/immunotherapy, or a combination regimen) for metastatic disease. This
includes development of any new lesion or a 20% increase in the sum of the subject's
measurable disease compared to their previous nadir. New CNS metastasis could be the
reason for disease progression, but they must be stable clinically and satisfy
criteria delineated in section 5.4. Prior systemic therapy must have been completed
at least 28 days before registration.

- Subjects may have received prior biologic or immunotherapy given in an adjuvant
fashion. Prior adjuvant therapy must have been completed at least 28 days prior to
registration

- Subjects may have received prior radiation therapy. If all known sites of disease
have been previously radiated, there must be objective evidence of progression for
the subject to be eligible. Radiation therapy must have been completed at least 28
days before registration.

- Subjects may have received prior surgery. Prior surgery must have been completed at
least 28 days before registration.

- Performance status must be 0-2 according to Southwest Oncology Group Criteria

Performance Status:

GRADE SCALE

0 Fully active; able to carry on all pre-disease activities without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work
of a light or sedentary nature, e.g., light housework, office work.

2. Ambulatory and capable of all self care but unable to carry out any work activities.
Up and about more than 50% of waking hours.

3. Capable of only limited self care; confined to bed or chair more than 50% of waking
hours.

4. Completely disabled. Cannot carry on any self care. Totally confined to bed or chair.

5. Dead

- Subjects must have a normal ECG, without evidence of congestive heart failure.

1. Normal heart rate (less than 100 per minute)

2. Normal sinus rhythm

3. Normal interval from the beginning of the Q wave to the termination of the
S wave, representing the time for ventricular depolarization (QRS) interval

4. Subjects with QT prolongation > 500msec on their ECG will be considered
ineligible.

Exclusion Criteria:

- Pregnant or nursing women are not eligible to participate in this trial because
the safe use of this drug in pregnancy has not been established.

- Subjects with severe myocardial disease or coronary occlusion, psychoses, and
hypersensitivity to disulfiram or other thiuram derivatives used in pesticides
and rubber vulcanization are excluded from the study.

- Subjects who can not abstain from alcohol intake during the entire duration of
this protocol are not qualified for this study.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Tolerability of disulfiram in combination with arsenic trioxide

Outcome Time Frame:

Up to 6 years

Safety Issue:

Yes

Principal Investigator

John P Fruehauf, M.D. PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chao Family Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UCI 06-08

NCT ID:

NCT00571116

Start Date:

September 2006

Completion Date:

August 2012

Related Keywords:

  • Metastatic Melanoma
  • Metastatic Melanoma
  • Disulfiram
  • Arsenic Trioxide
  • Metastatic Melanoma and at Least One Prior Systemic Therapy
  • Melanoma

Name

Location

Chao Family Comprehensive Cancer Center, University of California, IrvineOrange, California  92868