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CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma


OBJECTIVES:

- Determine the response rate of patients with recurrent or refractory stage II or III
multiple myeloma treated with arsenic trioxide and dexamethasone.

- Determine the rates of overall and relapse-free survival in patients treated with this
regimen.

- Determine the safety profile of this treatment regimen in these patients.

OUTLINE: Patients receive arsenic trioxide IV daily for 5 days during the first week only
and then 2 days a week thereafter. Patients also receive IV or oral dexamethasone on days
1-4 every 4 weeks. Treatment continues in the absence of disease progression or unacceptable
toxicity. Disease assessments are conducted every 4 weeks. Patients achieving complete
response (CR) receive 2 additional courses of therapy after initial determination of CR.

Final assessments are conducted 4 weeks after the last study treatment and then annually
thereafter.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of stage II or III multiple myeloma

- Refractory myeloma defined as progressive disease (more than 25% increase in M
protein or in radiographic findings of nonsecretory myeloma) despite up to 3 courses
of prior cytotoxic chemotherapy

- No more than 3 prior cytotoxic regimens

- No more than 1 prior high-dose cytotoxic regimen with stem cell transplantation

- History of disease progression after prior steroid antimyeloma therapy

- No smoldering myeloma

- Measurable disease based on presence of serum and urine M protein and/or measurable
plasmacytoma

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- Karnofsky 70-100%

Life expectancy:

- At least 3 months

Hematopoietic:

- Absolute granulocyte count greater than 1,200/mm^3*

- Platelet count greater than 75,000/mm^3*

- Hemoglobin greater than 10 g/dL* NOTE: *Unless due to multiple myeloma

Hepatic:

- Bilirubin no greater than 2 times upper limit of normal (ULN)

- SGOT and SGPT no greater than 2 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- Absolute QT interval less than 460 msec in the presence of normal potassium and
magnesium levels

- No significant underlying cardiac dysfunction

- No conduction defects

- No unstable angina

- No congestive heart failure

- No New York Heart Association class II-IV cardiac disease

- No myocardial infarction within the past 6 months

Other:

- No preexisting grade 2 or greater neurotoxicity/neuropathy

- No other malignancy within the past 5 years except curatively treated carcinoma in
situ of the cervix or nonmelanoma skin cancer

- No uncontrolled diabetes mellitus

- No active serious infection uncontrolled by antibiotics

- No history of grand mal seizures (other than infantile febrile seizures)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

- See Chemotherapy

- At least 28 days since prior biologic therapy

Chemotherapy:

- See Disease Characteristics

- At least 28 days since prior cytotoxic chemotherapy, including high-dose cytotoxic
regimen with stem cell transplantation

- No other concurrent cytotoxic chemotherapy

Endocrine therapy:

- See Disease Characteristics

Radiotherapy:

- At least 28 days since prior radiotherapy except for focal radiation for symptom
control

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Scott C. Stromatt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cell Therapeutics

Authority:

United States: Federal Government

Study ID:

CDR0000068646

NCT ID:

NCT00017069

Start Date:

February 2001

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Mountain States Tumor Institute - BoiseBoise, Idaho  83712
St. Joseph Hospital Regional Cancer Center - OrangeOrange, California  92868-3849
Arizona Clinical Research CenterTucson, Arizona  85712
Texas Cancer CareFort Worth, Texas  76104
Highlands Oncology Group - SpringdaleSpringdale, Arkansas  72764
Stockton Hematology Oncology Medical GroupStockton, California  95204
Rocky Mountain Cancer Centers - MidtownDenver, Colorado  80218
Pasco Pinellas Cancer Center - Tarpon SpringsTarpon Springs, Florida  34689