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A Phase I Trial of EMD 121974 in Patients With Advanced or Metastatic Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Precancerous/Nonmalignant Condition, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Trial of EMD 121974 in Patients With Advanced or Metastatic Cancer


OBJECTIVES: I. Determine the safety and tolerability of EMD 121974 in patients with advanced
or metastatic cancer. II. Correlate various surrogate markers of antiangiogenic activity
with EMD 121974 therapy including magnetic resonance imaging and PET scans, serum assays for
various angiogenic and antiangiogenic factors, serum and urine markers of calcium
metabolism, and tumor biopsies.

OUTLINE: This is a dose-escalation study. Patients receive EMD 121974 IV over 1 hour twice
weekly for 4 weeks. Treatment continues for an additional course in the absence of
unacceptable toxicity. Patients with stable or responding disease may continue therapy
indefinitely past the 2 courses until disease progression. Cohorts of 3-6 patients receive
escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD
is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose
limiting toxicities. Patients are followed every 3 months for the first year, and then every
4 months thereafter until disease progression.

PROJECTED ACCRUAL: A total of 31-40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced or
metastatic cancer that is considered incurable and for which no standard curative therapy
exists No primary CNS malignancies Measurable evidence of residual, recurrent, or
metastatic disease No prior CNS metastases with residual abnormal findings on
neuroradiologic studies Prior CNS metastases allowed provided at least 6 months from
definitive therapy and a normal CT or MRI of the brain

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Hemoglobin at
least 9 mg/dL (may be post transfusion) Platelet count at least 100,000/mm3 Hepatic:
Bilirubin normal SGOT/SGPT no greater than 2.5 times upper limit of normal PT/PTT normal
Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception No active infection
requiring parenteral antibiotics No documented abnormal CNS exam with seizure disorder or
major neuropsychiatric problems

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior hematopoietic
growth factor or cytokine therapy and recovered No concurrent immunotherapy Chemotherapy:
At least 4 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas or
mitomycin) and recovered No concurrent chemotherapy Endocrine therapy: No concurrent
corticosteroids except for steroid replacement therapy or chronic low dose (no greater
than 10 mg/day oral prednisone) therapy for nonmalignant conditions No concurrent hormonal
therapy except oral contraceptives or hormonal replacement therapy Radiotherapy: At least
2 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At
least 2 weeks since prior surgery and recovered Other: At least 4 weeks since other prior
investigational drugs No concurrent oral or parenteral anticoagulants except
anticoagulants for central venous catheters including low dose warfarin (1-2 mg/day)
and/or heparin No concurrent oral COX-2 specific inhibitors (e.g., celecoxib or rofecoxib)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the safety and tolerability of escalating doses of twice weekly EMD 121974 in patients with cancer.

Outcome Time Frame:

enrollement through termination

Safety Issue:

Yes

Principal Investigator

Michael S. Gordon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea

Authority:

United States: Federal Government

Study ID:

9909-40; T99-0076

NCT ID:

NCT00004258

Start Date:

December 1999

Completion Date:

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Precancerous/Nonmalignant Condition
  • Small Intestine Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • monoclonal gammopathy of undetermined significance
  • recurrent adult Hodgkin lymphoma
  • stage I cutaneous T-cell non-Hodgkin lymphoma
  • stage II cutaneous T-cell non-Hodgkin lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • isolated plasmacytoma of bone
  • extramedullary plasmacytoma
  • refractory multiple myeloma
  • Waldenstrom macroglobulinemia
  • stage III multiple myeloma
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • refractory chronic lymphocytic leukemia
  • small intestine lymphoma
  • unspecified adult solid tumor, protocol specific
  • chronic phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • meningeal chronic myelogenous leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • polycythemia vera
  • essential thrombocythemia
  • untreated hairy cell leukemia
  • progressive hairy cell leukemia, initial treatment
  • refractory hairy cell leukemia
  • chronic myelomonocytic leukemia
  • T-cell large granular lymphocyte 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 III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt 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
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • secondary acute myeloid leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • prolymphocytic leukemia
  • primary systemic amyloidosis
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • chronic idiopathic myelofibrosis
  • 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
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Neoplasm Metastasis
  • Precancerous Conditions
  • Lymphoma, Large-Cell, Immunoblastic
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Intestinal Neoplasms

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265