NCT00060203

Brief Summary

RATIONALE: Drugs used in chemotherapy such as brostallicin use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of brostallicin in treating patients who have recurrent or refractory multiple myeloma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2003

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
Last Updated

January 16, 2014

Status Verified

January 1, 2014

Enrollment Period

3 months

First QC Date

May 6, 2003

Last Update Submit

January 14, 2014

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage III multiple myelomarefractory multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • Objective Tumor Response Rate

    • Determine the objective tumor response rate (confirmed complete response and confirmed partial response) of brostallicin in patients with recurrent or refractory multiple myeloma

    1 year

Secondary Outcomes (6)

  • Maximum Tolerated Dose of brostallicin

    1 year

  • Time to response

    1 year

  • Duration of Response

    1 year

  • Time to treatment failure

    1 year

  • Time to tumor progression

    1 year

  • +1 more secondary outcomes

Study Arms (1)

Brostallicin

EXPERIMENTAL
Drug: brostallicin

Interventions

brostallicinDRUG

Patients receive brostallicin IV over 10-30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of brostallicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

Brostallicin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Confirmed diagnosis of multiple myeloma based on prior or current demonstration of the following criteria\*: * Major criteria: * Plasmacytoma on tissue biopsy * Bone marrow plasmacytosis with at least 30% plasma cells * Monoclonal globulin spike on serum electrophoresis exceeding 3.5 g/dL for IgG peaks or 2.0 g/dL for IgA peaks; greater than 1,000 mg/24hr of kappa or gamma light chain excretion on urine electrophoresis in the absence of amyloidosis * Minor criteria: * Bone marrow plasmacytosis with 10% to 30% plasma cells * Monoclonal globulin spike present but less than levels in major criterion III above * Lytic bone lesions * Residual normal immunoglobulin M (IgM) no greater than 0.5 g/dL, IgA no greater than 0.1 g/dL, or IgG no greater than 0.6 g/dL NOTE: \*Diagnosis of multiple myeloma requires a minimum of 1 major and 1 minor criterion (I and a together is not sufficient; must be I and b, I and c, I and d; II and b, II and c, II and d; III and a, III and c, III and d) or 3 minor criteria that must include a and b (a, b, and c; a, b, and d) * Measurable disease defined by 1 of the following values: * Serum myeloma (M) protein (IgG or IgA) level greater than 1.0 g/dL * Urine M protein (light chain disease) at least 300 mg/24hr * Soft tissue plasmacytoma with bidimensional measurement at least 20 x 20 mm (10 x 10 mm if spiral CT scan is used) * Must have progressed during or within 12 months of discontinuing prior myelosuppressive chemotherapy (e.g., vincristine, doxorubicin, and dexamethasone (VAD) or melphalan) OR not responded after 2 courses of prior myelosuppressive chemotherapy * No indolent or smoldering myeloma or localized plasmacytoma * No known brain or leptomeningeal disease unless such lesions were previously irradiated, are currently not being treated with corticosteroids, and are associated with no clinical symptoms PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 (at least 1,000/mm\^3 if neutropenia due to replacement of the normal bone marrow cells by myeloma cells) * Platelet count at least 100,000/mm\^3 (at least 50,000/mm\^3 if thrombocytopenia due to replacement of the normal bone marrow cells by myeloma cells) * Hemoglobin at least 8.0 g/dL (no transfusion allowed) * No hyperviscosity syndrome Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * Serum glutamate oxaloacetate transaminase (SGOT) no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal * Creatinine no greater than 3.0 times ULN * Calcium no greater than 12 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and sampling for study analysis * HIV negative * No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix * No AIDS-related illness * No active infectious process or other severe concurrent disease that would make the patient inappropriate for study entry * No mental incapacity or psychiatric illness that would preclude giving informed consent or completing follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * See Chemotherapy * No concurrent anticancer biological response modifiers * No concurrent immunotherapy * No concurrent sargramostim (GM-CSF) Chemotherapy * See Disease Characteristics * More than 2 years since prior high-dose chemotherapy with autologous bone marrow transplantation or stem cell support * More than 4 weeks since prior myelosuppressive chemotherapy * No other concurrent anticancer chemotherapy Endocrine therapy * See Disease Characteristics * No concurrent anticancer hormonal therapy * No concurrent chronic steroids * Acute pulse dosing required for treatment of a concurrent medical condition is allowed, provided treatment duration is no greater than 2 weeks * No concurrent corticosteroids (e.g., dexamethasone) Radiotherapy * More than 14 days since prior radiotherapy * No prior radiotherapy to more than 25% of bone marrow * No plans for radiotherapy within the next 6 months * Concurrent palliative radiotherapy for skeletal pain allowed Surgery * More than 14 days since prior surgery * No plans for surgery within the next 6 months Other * Acute toxic effects of prior therapy (except for alopecia and neurotoxicity) must have resolved to grade 0, 1, or the patient's baseline * Treatment-related neurotoxicity must have resolved to the patient's baseline, not to exceed grade 2 * Chronic bisphosphonates for bone pain allowed only for maintenance doses * More than 2 weeks since prior nonmyelosuppressive antimyeloma therapy * More than 2 weeks since prior macrolide antibiotics * No other concurrent investigational agents * No concurrent macrolide antibiotics * No concurrent participation in another treatment clinical study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

brostallicin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Hillard M. Lazarus, MD

    Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2003

First Posted

May 7, 2003

Study Start

December 1, 2002

Primary Completion

March 1, 2003

Study Completion

April 1, 2004

Last Updated

January 16, 2014

Record last verified: 2014-01

Locations

US(1)