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Drug/Agent Toxicity by Tissue/OrganPhase 1NCT00052884

Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation

A Phase 1 study testing filgrastim, amifostine trihydrate and melphalan in people with Drug/Agent Toxicity by Tissue/Organ and Multiple Myeloma and Plasma Cell Neoplasm, run by Eastern Cooperative Oncology Group at 16 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a peripheral stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher dose of chemotherapy to be given so that… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
filgrastim, amifostine trihydrate and melphalan
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
16 sitesUnited States
Study dates
22 Jan 2004to Mar 2011
Phase
Phase 1
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed amyloidosis
  • No secondary familial or localized amyloidosis
  • Presence of monoclonal protein by immunoelectrophoresis or immunofixation of serum or urine
  • No primary amyloidosis manifested only by carpal tunnel syndrome or purpura
  • Amyloid deposits in a plasmacytoma or in bone marrow vessels in an asymptomatic individual not considered an amyloid syndrome
  • Amyloid syndromes include any of the following:
  • Hepatomegaly
  • Cardiomyopathy
  • Nephrotic range proteinuria
  • Peripheral or autonomic neuropathy
  • No multiple myeloma defined by 1 of the following:
  • Presence of lytic bone disease
  • More than 30% bone marrow plasma cells

PATIENT CHARACTERISTICS:

Age

  • 18 to 70

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count at least 100,000/mm^3

Hepatic

  • See Disease Characteristics
  • Total or direct bilirubin no greater than 2.0 mg/dL
  • Alkaline phosphatase no greater than 4 times upper limit of normal

Renal

  • See Disease Characteristics
  • Creatinine less than 3.0 mg/dL

Cardiovascular

  • See Disease Characteristics
  • Ejection fraction at least 45% by echocardiogram
  • No New York Heart Association class III or IV heart disease
  • Systolic blood pressure ≥ 90 mmHg

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection
  • No other malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix, nonmelanoma skin cancer, or indolent prostate cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior interferon

Chemotherapy

  • At least 4 weeks since prior melphalan
  • Lifetime total melphalan dose less than 150 mg/m^2 (based on ideal body weight)

Endocrine therapy

  • At least 4 weeks since prior dexamethasone

Radiotherapy

  • No prior radiotherapy for amyloidosis

Surgery

  • Not specified

Other

  • No antihypertensive medications for at least 24 hours prior to, during, and for 1 hour after amifostine administration
  • No other prior treatment

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Cancer Center

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Minnesota Oncology Hematology, PA - Woodbury

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

Official title: A Phase I Study of Amifostine Followed by High-Dose Escalation of Melphalan With Stem Cell Reconstitution for Patients With Primary Systemic Amyloidosis

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a peripheral stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher dose of chemotherapy to be given so that more plasma cells are killed. Giving a chemoprotective drug such as amifostine may protect kidney cells from the side effects of chemotherapy.

PURPOSE: This phase I trial is studying the side effects and best dose of melphalan given together with amifostine in treating patients who are undergoing peripheral stem cell transplant for primary systemic amyloidosis.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose (MTD) of high-dose melphalan administered with amifostine in patients with primary systemic amyloidosis undergoing autologous peripheral blood stem cell transplantation.
  • Determine the toxicity of high-dose melphalan when administered at the MTD in these patients.
  • Determine the response rate in patients treated with this regimen.

OUTLINE: This is a nonrandomized, multicenter, dose-escalation study of melphalan.

Patients receive filgrastim (G-CSF) subcutaneously once daily until peripheral blood stem cell (PBSC) collection is complete. Apheresis begins on day 5 of G-CSF administration and continues until the target number of PBSCs are collected.

Within 6 weeks of PBSC collection, patients receive amifostine IV over 5 minutes on days -2 and -1 and high-dose melphalan IV over 30-60 minutes on day -1. Patients undergo autologous PBSC infusion on day 0.

Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients are treated at that dose.

Patients are followed approximately 3 months following transplantation, then every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 3-46 patients will be accrued for this study within 2.3 years.

Being tested
filgrastim, amifostine trihydrate, melphalan, bone marrow ablation with stem cell support, peripheral blood stem cell transplantation
Keywords
drug/agent toxicity by tissue/organ, primary systemic amyloidosis
Medical subject headings
Drug-Related Side Effects and Adverse Reactions, Multiple Myeloma, Neoplasms, Plasma Cell, Immunoglobulin Light-chain Amyloidosis

What participants receive

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

Study groups in NCT00052884
Study groupRoleWhat they receive
Amifostine, Melphalan, and Stem Cell ReconstitutionExperimentalAmifostine, Melphalan, and Stem Cell Reconstitution. Doses of Melphalan tested included 100 mg/m2 and 120 mg/m2
Receives: Biological: filgrastim; Drug: amifostine trihydrate; Drug: melphalan; Procedure: bone marrow ablation with stem cell support; Procedure: peripheral blood stem cell transplantation

What is being measured

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

  1. Maximum Tolerated Dose

    The maximum tolerated dose is the highest dose level at which fewer than 1 of 3 or 2 of 6 patients experience dose-limiting toxicity, defined as any grade 3 or higher toxicity of any of the following: renal failure, alkaline phosphatase elevation, GI bleeding, and cardiac rhythm disturbances, assessed using NCI Common Toxicity Criteria, version 2.0.

    Measured: Assessed over 30 days

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study start22 Jan 2004
  3. Primary completionSep 2007
  4. Study completionMar 2011

Why it stopped: Slow accrual and changes in clinical practice

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00052884
Sponsor's protocol ID
CDR0000258785
Other IDs
U10CA021115, ECOG-E2A01
Status last verified
Jun 2023
First submitted
24 Jan 2003
Last updated
18 Jun 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing filgrastim, amifostine trihydrate and melphalan in people with Drug/Agent Toxicity by Tissue/Organ and Multiple Myeloma and Plasma Cell Neoplasm, run by Eastern Cooperative Oncology Group at 16 sites 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: stopped early, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was stopped early (reason given: Slow accrual and changes in clinical practice). Results are not available in the source record.

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?

Maximum Tolerated Dose (time frame: Assessed over 30 days). 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 NCT00052884.

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 18 Jun 2023.

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