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A Phase I and Pharmacologic Study of UCN-01 (NSC638850)


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I and Pharmacologic Study of UCN-01 (NSC638850)


OBJECTIVES: I. Determine the toxicity profile, dose limiting toxicity, and maximum tolerated
dose of UCN-01 administered as a 3, 2, or 1 hour infusion every 4 weeks for patients with
advanced solid tumor malignancies and chronic lymphoproliferative disorders. II. Investigate
the pharmacokinetics and cellular pharmacodynamics of UCN-01 administered on this schedule
in these patients. III. Obtain preliminary evidence of the antitumor activity of UCN-01 in
this patient population.

OUTLINE: This is dose escalation study. Patients receive UCN-01 by intravenous infusions
over 3, 2 or 1 hour(s) every 4 weeks. The first dose level is administered over 3 hours, the
next dose level is administered over 2 hours, and the next and subsequent dose levels are
administered over 1 hour. One patient is treated at each dose level until unacceptable
toxicity is observed. An additional 2 patients are then entered at that dose level. If dose
limiting toxicity (DLT) is experienced in 1 of 3 patients, 3 additional patients are accrued
at that dose level. If 2 or more patients experience DLT, the maximum tolerated dose has
been surpassed and a total of 6 patients must be treated at the previous dose level. If no
patients develop DLT, the dose is escalated in successive cohorts of 3 patients per dose
level. Patients are followed for 4 weeks after each drug administration before subsequent
patients can be entered at the next higher dose level. Patients are followed for 2 months
after their last dose of UCN-01.

PROJECTED ACCRUAL: Approximately 36 patients will be accrued into this study over 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed malignancy that is refractory to
standard therapy or for which no standard therapy exists Low grade lymphoproliferative
disorder defined as: Chronic lymphocytic leukemia/small lymphocytic lymphoma Waldenstrom's
macroglobulinemia Follicular lymphoma (small cleaved, mixed, and large cell) Mantle cell
lymphoma Prolymphocytic leukemia (T and B type) Cutaneous T cell non-Hodgkin's lymphoma
Marginal zone lymphoma and variants Hairy cell leukemia variants MALT lymphomas Patients
with low grade lymphoproliferative disorders must have received at least 1 or more
treatment regimens and must not be eligible for potentially curative treatments (i.e.,
bone marrow transplantation) No HTLV-1 associated lymphomas, Burkitt's or small
non-cleaved lymphomas, transplant related lymphoproliferative disorders, Hodgkin's
disease, diffuse large cell lymphoma, or multiple myeloma No primary brain tumors or
history of brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet
count greater than 100,000/mm3 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin no greater
than 1.2 mg/dL AST/ALT less than 2.5 times upper limit of normal Renal: Creatinine no
greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No
history of unstable or newly diagnosed angina pectoris No myocardial infarction within the
last 6 months No New York Heart Association class II-IV congestive heart failure
Neurologic: No grade 2 or greater peripheral neuropathy Pulmonary: No grade 2 or greater
pulmonary toxicity (dyspnea on significant exertion) Other: HIV negative No autoimmune
hemolytic anemia Must be able to have a central venous access catheter No active
infections requiring oral or intravenous antibiotics No medical or psychiatric problems
unrelated to the malignancy that may limit compliance with study, expose patient to undue
risk, or confound toxicity assessment Not pregnant or nursing Adequate contraception is
required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 month since prior platelet or red
blood cell transfusions Chemotherapy: At least 6 weeks since nitrosoureas or mitomycin At
least 4 weeks since other chemotherapy No investigational or standard chemotherapy for at
least 2 months after completion of last dose of UCN-01 Endocrine therapy: Not specified
Radiotherapy: At least 4 weeks since radiotherapy Surgery: At least 4 weeks since major
surgery Other: No concurrent anticonvulsant medications

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ross C. Donehower, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

JHOC-J9814, CDR0000066221

NCT ID:

NCT00003289

Start Date:

June 1998

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Waldenstrom macroglobulinemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • refractory chronic lymphocytic leukemia
  • unspecified adult solid tumor, protocol specific
  • refractory hairy cell leukemia
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • prolymphocytic leukemia
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Johns Hopkins Oncology CenterBaltimore, Maryland  21287