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Stage II Multiple MyelomaPhase 2NCT00085345

Melphalan, Arsenic Trioxide, and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma

A Phase 2 study testing arsenic trioxide, ascorbic acid and melphalan in people with Stage II Multiple Myeloma and Stage III Multiple Myeloma, run by Oncotherapeutics at 19 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as melphalan, arsenic trioxide, and ascorbic acid, work in different ways to stop cancer cells from dividing so they stop growing or die. Arsenic trioxide and ascorbic acid may also help melphalan kill more cancer cells by making them more sensitive to the drugs. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
arsenic trioxide, ascorbic acid and melphalan
Type of treatment
Surgery or procedure
How many people
0 participants
Where
19 sitesUnited States
Study dates
Start not givento not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma meeting at least 1 of the following criteria:
  • Relapsed disease after a response to standard first-line chemotherapy (e.g., vincristine, doxorubicin, and dexamethasone [VAD] OR melphalan and prednisone) or first-line high-dose chemotherapy
  • Refractory disease (failed to achieve at least stable disease) to most recent chemotherapy with or without systemic corticosteroids
  • Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of ≥ 1 g/dL AND/OR urine monoclonal immunoglobulin spike of ≥ 200 mg/24 hours
  • No non-secretory myeloma
  • No plasma cell leukemia

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • More than 3 months

Hematopoietic

  • Platelet count ≥ 50,000/mm^3 (30,000/mm^3 if bone marrow is extensively infiltrated)
  • Hemoglobin ≥ 8.0 g/dL
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Pancytopenia secondary to multiple myeloma or hypersplenism allowed

Hepatic

  • AST and ALT ≤ 3 times upper limit of normal (ULN)
  • Bilirubin ≤ 2 times ULN (unless clearly related to disease)
  • No known active hepatitis B or C infection

Renal

  • Calcium < 14 mg/dL

Cardiovascular

  • No evidence of acute ischemia or new conduction system abnormality by electrocardiogram
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class III or IV heart failure
  • No poorly controlled hypertension
  • No prolonged corrected QT interval (> 460 ms) with potassium > 4 mmol/L and magnesium ≥ 1.8 mmol/L

Other

  • No active infection
  • No POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  • No diabetes mellitus
  • No other serious medical or psychiatric illness that would preclude study participation
  • No known allergic reaction attributable to compounds of similar chemical or biological composition to study drugs
  • No history of grand mal seizures
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior immunotherapy or antibody therapy

Chemotherapy

  • See Disease Characteristics
  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy

  • See Disease Characteristics
  • No other concurrent corticosteroids

Radiotherapy

  • More than 4 weeks since prior radiotherapy

Surgery

  • More than 4 weeks since prior major surgery

Other

  • No other concurrent investigational agents

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites
  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309-0633

  • Center for Cancer and Blood Disorders at Suburban Hospital

    Bethesda, Maryland, 20817

  • Southbay Oncology / Hematology Medical Group

    Campbell, California, 95008

  • Study site

    Fountain Valley, California, 92708

  • Hematology-Oncology Medical Group of Fresno, Incorporated

    Fresno, California, 93720

  • Palo Verde Hematology Oncology

    Glendale, Arizona, 85304

  • Hackensack University Medical Center Cancer Center

    Hackensack, New Jersey, 07601

  • Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Tulane Cancer Center at Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112-2699

  • Hematology Oncology Medical Group of Orange County, Incorporated

    Orange, California, 92868

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

  • Cancer Care Associates Medical Group - Redondo Beach

    Redondo Beach, California, 90277

  • Atlanta Cancer Care - Roswell

    Roswell, Georgia, 30076

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Utah Cancer Specialists - Administrative Office

    Salt Lake City, Utah, 84106

  • Redwood Regional Oncology Center - Sotoyome

    Santa Rosa, California, 95405

  • Cancer Prevention and Treatment Center at Dominican and Watsonville Community Hospital

    Soquel, California, 95073

  • San Diego Cancer Center - Vista

    Vista, California, 92083

  • Oncotherapeutics

    West Hollywood, California, 90069

Other trials in United States

About this study

Official title: Phase II Study of Melphalan, Arsenic Trioxide, and Ascorbic Acid in Patients With Relapsed or Refractory Multiple Myeloma

RATIONALE: Drugs used in chemotherapy, such as melphalan, arsenic trioxide, and ascorbic acid, work in different ways to stop cancer cells from dividing so they stop growing or die. Arsenic trioxide and ascorbic acid may also help melphalan kill more cancer cells by making them more sensitive to the drugs.

PURPOSE: This phase II trial is studying how well giving melphalan together with arsenic trioxide and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the time to progression in patients with relapsed or refractory multiple myeloma (MM) treated with melphalan, arsenic trioxide, and ascorbic acid.
  • Determine the response rate (combined complete response, partial response, and minimal response) in patients treated with this regimen.
  • Determine the safety and tolerability of this regimen in these patients.

Secondary

  • Determine the time to response and overall survival of patients treated with this regimen.
  • Determine the effects of this regimen on renal failure associated with MM in these patients.

OUTLINE: This is an open-label, non-randomized, multicenter study.

Patients receive oral melphalan once daily on days 1-4 of week 1 and arsenic trioxide (ATO) IV over 1-2 hours and ascorbic acid IV over 15 minutes on days 1-4 of week 1 and then twice weekly during weeks 2-5. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression any time after course 1 also receive oral prednisone once daily on days 1-4 and 22-25 of each course. Patients achieving a complete response after 6 courses of therapy undergo bone marrow biopsy and receive no further therapy. Patients achieving stable disease or a partial response after 6 courses of therapy continue to receive ATO and ascorbic acid once weekly.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.

Being tested
arsenic trioxide, ascorbic acid, melphalan, chemosensitization/potentiation, chemotherapy
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • arsenic trioxideDrug

  • ascorbic acidDrug

  • melphalanDrug

  • chemosensitization/potentiationProcedure or surgery

  • chemotherapyProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2004 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00085345
Sponsor's protocol ID
ONCOTHER-MAC001
Other IDs
CDR0000368637
Status last verified
Jul 2006
First submitted
10 Jun 2004
Last updated
10 Jul 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing arsenic trioxide, ascorbic acid and melphalan in people with Stage II Multiple Myeloma and Stage III Multiple Myeloma, run by Oncotherapeutics at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2013.

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