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Breast CancerPhase 2NCT00060255

High-Dose Chemotherapy, Total-Body Irradiation, and Autologous Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Hematologic Cancer or Solid Tumors

A Phase 2 study testing busulfan, carboplatin and carmustine in people with Breast Cancer and Leukemia, run by Roswell Park Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 4 years and older
Conditions the study is for
Breast Cancer, Leukemia, Lymphoma
What is being tested?
busulfan, carboplatin and carmustine
How many people
451 participants
Where
1 siteUnited States
Study dates
Dec 1991to Feb 2013
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 4 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed hematologic or solid tumor malignancy, including any of the following:
  • Acute myeloid leukemia
  • First remission and not eligible for allogeneic transplantation; recurrent disease after combination chemotherapy with at least 1 standard regimen; or second remission
  • Not eligible for protocol CLB-9620 or CLB-9621
  • Acute lymphoblastic leukemia
  • First complete remission without appropriate allogeneic donor
  • Chronic myelogenous leukemia
  • Chronic, accelerated, or blast phase
  • Lymphoproliferative diseases*
  • Chronic lymphocytic leukemia
  • Multiple myeloma
  • Waldenstrom's macroglobulinemia
  • Low-grade non-Hodgkin's lymphoma (NHL) NOTE: *Recurrent or persistent, symptomatic disease after first-line chemotherapy, or subsequently
  • Amyloidosis
  • Primary or previously treated disease
  • NHL (intermediate- and high-grade)
  • Resistant or recurrent disease after combination chemotherapy with at least 1 standard regimen
  • First remission lymphoblastic or small, non-cleaved cell lymphoma at high risk of relapse
  • CNS disease OR bone marrow disease and lactic dehydrogenase greater than 300 IU/L
  • Hodgkin's lymphoma
  • Resistant or recurrent disease after combination chemotherapy with at least 1 standard regimen
  • Solid tumors
  • High-risk and metastatic breast cancer
  • Testicular cancer that has relapsed OR primary progressive disease that is responding to salvage therapy
  • Other solid tumors that have recurred after conventional therapy OR are at high risk for relapse, and demonstrate chemosensitivity
  • Less than 10% marrow tumor present histologically (maximum of 15% involvement allowed if purged)
  • Allogeneic marrow transplantation not possible or not desirable for any of the following reasons:
  • Over 60 years of age
  • No compatible donor identified
  • Estimated risk of graft-versus-host disease complications greater than risk of recurrence after autologous bone marrow transplantation
  • Patients with disease progression in a site of prior radiotherapy (4,000 cGy or more) are not eligible for total body irradiation (TBI) regimens
  • Hormone receptor status:
  • Not specified NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age

  • 4 and over (patients 60 years of age and over are not eligible for TBI)

Sex

  • Male or female

Menopausal status

  • Not specified

Performance status

  • Karnofsky 70-100%

Life expectancy

  • More than 2 months

Hematopoietic

  • WBC greater than 3,000/mm^3*
  • Polymorphonuclear leukocyte count greater than 1,500/mm^3*
  • Platelet count greater than 75,000/mm^3*
  • Marrow cellularity greater than 20%*
  • No marrow fibrosis* NOTE: *Before marrow storage

Hepatic

  • Bilirubin less than 3 times normal
  • Alkaline phosphatase less than 3 times normal
  • AST less than 3 times normal
  • Hepatitis status known

Renal

  • Creatinine clearance at least 50 mL/min (not required for patients with amyloidosis or multiple myeloma)

Cardiovascular

  • Ventricular ejection fraction at least 50% by radionuclide ventriculogram or echocardiogram
  • No myocardial infarction within the past 6 months
  • No congestive heart failure
  • No symptomatic angina
  • No life-threatening arrhythmia or hypertension

Pulmonary

  • DLCO or DLVA at least 50% of predicted (DLCO must be corrected for hemoglobin and/or alveolar ventilation)

Other

  • Not pregnant
  • HIV negative
  • Cytomegalovirus status known
  • No active bacterial, viral, or fungal infection
  • No active peptic ulcer disease
  • No uncontrolled diabetes mellitus
  • No serious organ dysfunction unless it is caused by the underlying disease
  • No other serious medical or psychiatric illness that would preclude giving informed consent or complying with study requirements

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • See Disease Characteristics
  • No prior cumulative nitrosourea dose greater than 600 mg/m^2
  • No prior cumulative bleomycin dose greater than 150 units/m^2
  • No prior cumulative doxorubicin dose greater than 450 mg/m^2
  • No prior cumulative daunorubicin dose greater than 600 mg/m^2
  • Patients with prior high-dose cyclophosphamide (greater than 150 mg/kg per cycle) and high-dose etoposide (greater than 2,400 mg/m^2 per cycle) are not eligible for the etoposide/cyclophosphamide/TBI conditioning regimen

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • More than 3 weeks since prior radiotherapy (before blood stem cell harvest)
  • Prior cumulative doses of radiotherapy must not exceed the following:
  • Spine/spinal cord: 4,000 cGy
  • Mediastinum: 4,000 cGy
  • Heart: 4,000 cGy
  • Kidney (whole): 1,500 cGy
  • Small bowel: 4,000 cGy
  • Brain: 4,000 cGy
  • Liver (whole): 2,000 cGy
  • Lungs (whole): 1,500 cGy
  • Bone: 5,000 cGy

Surgery

  • Not specified

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

Other trials in United States

About this study

Official title: Autologous Blood and Marrow Transplantation for Hematologic Malignancy and Selected Solid Tumors

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation or autologous bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well eight different high-dose chemotherapy regimens with or without total-body irradiation followed by autologous stem cell transplantation or autologous bone marrow transplantation works in treating patients with hematologic malignancies or solid tumors.

Read the detailed description

OBJECTIVES:

  • Determine the morbidity, mortality, and overall outcome in patients with hematologic malignancies, breast cancer, or other chemosensitive solid tumors treated with disease-specific dose-intensive conditioning regimens and autologous peripheral blood or bone marrow transplantation.

OUTLINE: Patients are stratified according to risk group (standard vs high). Standard risk includes acute leukemia in first relapse or second remission; lymphoma in responding first relapse or second remission; or breast cancer at risk for recurrence. High risk includes all others. Patients receive specific conditioning regimens according to diagnosis as outlined below.

Conditioning

  • Regimen A (standard risk non-Hodgkin's lymphoma and under 60 years of age)-Etoposide, cyclophosphamide, and total body irradiation (TBI) (VCT): Patients receive etoposide IV continuously over 26 hours beginning on day -5 and cyclophosphamide IV over 2 hours on day -4. Patients undergo TBI on days -3 to -1.
  • Regimen B (any risk Hodgkin's lymphoma and under 60 years of age)-Cyclophosphamide, carmustine, and etoposide (CBV): Patients receive etoposide IV continuously over 34 hours beginning on day -8; cyclophosphamide IV over 2 hours on days -7 to -4; and carmustine IV over 2 hours on day -3.
  • Regimen C (any risk patient with prior exposure to high-dose etoposide and cyclophosphamide and under 60 years of age)-Melphalan and TBI (MEL/TBI): Patients receive melphalan IV over 30 minutes on day -4. Patients undergo TBI on days -3 to -1.
  • Regimen D (multiple myeloma or amyloidosis)-Melphalan only (MEL only): Patients receive melphalan IV over 30 minutes on day -2.
  • Regimen E (any patient unable to receive TBI)-Busulfan and cyclophosphamide: Patients receive oral busulfan (or busulfan IV over 2 hours) on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
  • Regimen F (any risk breast cancer)-Cyclophosphamide, carboplatin, and thiotepa (STAMP V): Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4.
  • Regimen G (solid tumors other than breast or testicular cancer)-Thiotepa and carboplatin (TT/CARBO): Patients receive thiotepa IV over 2 hours on days -6 and -5 and carboplatin IV continuously over 96 hours beginning on day -6.
  • Regimen H (recurrent or primary progressive testicular cancer)-Etoposide and carboplatin (VP/CARBO): Patients receive etoposide IV over 2 hours and carboplatin IV over 30 minutes on days -6 to -4.

Stem Cell Infusion

  • In all regimens, patients undergo autologous stem cell infusion on day 0. Treatment continues in the absence of unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 450 patients (50 patients [25 per stratum] per regimen) will be accrued for this study within 10 years.

Being tested
busulfan, carboplatin, carmustine, cyclophosphamide, etoposide
Keywords
stage IV breast cancer, male breast cancer, recurrent malignant testicular germ cell tumor, Waldenstrom macroglobulinemia, childhood acute lymphoblastic leukemia in remission, adult acute lymphoblastic leukemia in remission, recurrent adult acute myeloid leukemia, adult acute myeloid leukemia in remission, recurrent childhood acute myeloid leukemia, childhood acute myeloid leukemia in remission, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma
Medical subject headings
Breast Neoplasms, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Testicular Germ Cell Tumor, Breast Neoplasms, Male, Testicular Neoplasms

What participants receive

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morbidity

    Measured: +day 100

  2. Mortality

    Measured: +day 100, +day 360

  3. Overall outcome

    Measured: every 6 months until death

  4. Response rate

    Measured: +day 100, +day 360

  5. Toxicity

    Measured: +day100, +day 360

  6. Disease-free survival

    Measured: up to 15years

  7. Overall survival

    Measured: every 6 months until death

Timeline

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

  1. First posted7 May 2003 (estimated)
  2. Study startDec 1991
  3. Primary completionAug 2006
  4. Study completionFeb 2013

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
451 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00060255
Sponsor's protocol ID
CDR0000301587
Other IDs
RPCI-DS-9115
Status last verified
May 2013
First submitted
6 May 2003
Last updated
9 May 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing busulfan, carboplatin and carmustine in people with Breast Cancer and Leukemia, run by Roswell Park Cancer Institute at 1 site 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: finished, as of the sponsor's last update on 9 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

What does the primary outcome measure?

Morbidity (time frame: +day 100). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00060255.

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 9 May 2013.

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Clinical Trial NCT00060255 | AzTrials