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Kidney CancerPhase 2NCT00027573

Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer

A Phase 2 study testing filgrastim, therapeutic allogeneic lymphocytes and cyclophosphamide in people with Kidney Cancer, run by Alliance for Clinical Trials in Oncology at 6 sites 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Read more about this study

Who is it for?
Ages Up to 60 years
Conditions the study is for
Kidney Cancer
What is being tested?
filgrastim, therapeutic allogeneic lymphocytes and cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
6 sitesUnited States
Study dates
Oct 2001to Jun 2006
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 Up to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed renal cell carcinoma (RCC)
  • Clear cell or papillary RCC
  • Granular tumors with sarcomatoid features
  • No purely sarcomatoid RCC, chromophobic RCC, or oncocytoma
  • No transitional cell carcinoma of the renal pelvis and collecting systems
  • Metastatic or unresectable disease
  • At least 1 measurable lesion
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • The following are not considered measurable:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Lymphangitis cutis/pulmonis
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • Cystic lesions
  • Primary bladder masses
  • Progressive disease after interferon alfa and/or interleukin-2 for metastatic RCC OR intolerance to these therapies
  • No prior or concurrent CNS metastases
  • Negative MRI of the brain within the past 28 days
  • Must have HLA-identical (6/6) sibling donor

PATIENT CHARACTERISTICS:

Age:

  • 60 and under

Performance status:

  • ECOG 0-1

Life expectancy:

  • More than 6 months

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST no greater than 3 times ULN

Renal:

  • Creatinine clearance at least 40 mL/min

Cardiovascular:

  • LVEF at least 45% by MUGA or echocardiogram

Pulmonary:

  • DLCO greater than 40% of predicted (corrected for hemoglobin level)
  • No symptomatic pulmonary disease

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No known hypersensitivity to E. coli-derived products
  • No uncontrolled diabetes mellitus
  • No active serious infection
  • No other concurrent malignancy except non-melanoma skin cancer or other malignancy that has less than a 30% risk of relapse after completion of therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No concurrent sargramostim (GM-CSF)
  • Concurrent epoetin alfa allowed

Chemotherapy:

  • No other concurrent chemotherapy

Endocrine therapy:

  • At least 28 days since prior hormonal therapy (e.g., megestrol, corticosteroids, or anti-estrogen therapy)
  • Concurrent steroids allowed for adrenal failure, graft-versus-host disease, or other nondisease-related conditions (e.g., insulin for diabetes)

Radiotherapy:

  • At least 14 days since prior radiotherapy

Surgery:

  • At least 14 days since prior surgery

Other:

  • At least 28 days since prior systemic therapy for RCC
  • Recovered from prior therapy

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • CCOP - Mayo Clinic Scottsdale Oncology Program

    Scottsdale, Arizona, 85259-5404

  • CCOP - Oklahoma

    Tulsa, Oklahoma, 74136

Other trials in United States

About this study

Official title: Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A Phase II Study

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have metastatic or unresectable kidney cancer.

Read the detailed description

OBJECTIVES:

  • Determine the overall response rate and overall and disease-free survival of patients with unresectable or metastatic renal cell cancer treated with fludarabine and cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation.
  • Determine the toxicity and treatment-related mortality of this regimen in these patients.
  • Determine the percentage of donor chimerism in patients treated with this regimen.
Conditions
Kidney Cancer
Being tested
filgrastim, therapeutic allogeneic lymphocytes, cyclophosphamide, fludarabine phosphate, methotrexate
Keywords
stage IV renal cell cancer, recurrent renal cell cancer, clear cell renal cell carcinoma, papillary renal cell carcinoma
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

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

Study groups in NCT00027573
Study groupRoleWhat they receive
Chemotherapy + stem cell transplantationExperimentalPatients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1-2 hours on days -4 and -3. Allogeneic peripheral blood stem cells are infused on day 0. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 5 and continuing until blood counts recover. Patients receive graft-versus-host disease (GVHD) prophylaxis comprising oral tacrolimus twice daily on days -1 to 90 and methotrexate IV on days 1, 3, and 6. After day 120, patients with persistent disease and no signs of active GVHD may receive donor lymphocyte infusion (DLI). DLI may be repeated every 8 weeks for a total of 2 infusions. Patients are followed every 2 months for 1 year and then every 6 months for 4 years OR every 2 months for 6 months and then every 6 months for 4.5 years if patient receives DLI.
Receives: Biological: filgrastim; Biological: therapeutic allogeneic lymphocytes; Drug: cyclophosphamide; Drug: fludarabine phosphate; Drug: methotrexate; Drug: tacrolimus; Procedure: peripheral blood stem cell transplantation

What is being measured

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

  1. Overall response rate

    Measured: Up to 5 years

  2. Overall survival

    Measured: Up to 5 years

  3. Disease-free survival

    Measured: Up to 5 years

  4. Treatment-related mortality

    Measured: Up to 5 years

  5. Percentage of donor chimerism in patients treated

    Measured: Up to 5 years

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 startOct 2001
  3. Primary completionJun 2006
  4. Study completionJun 2006

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
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00027573
Sponsor's protocol ID
CALGB-90003
Other IDs
U10CA031946, CALGB-90003, CDR0000069044
Status last verified
Jul 2016
First submitted
7 Dec 2001
Last updated
14 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Rini BI, Halabi S, Barrier R, Margolin KA, Avigan D, Logan T, Stadler WM, McCarthy PL, Linker CA, Small EJ; Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; Southwestern Oncology Group. Adoptive immunotherapy by allogeneic stem cell transplantation for metastatic renal cell carcinoma: a CALGB intergroup phase II study. Biol Blood Marrow Transplant. 2006 Jul;12(7):778-85. doi: 10.1016/j.bbmt.2006.03.011.

    PubMed 16785067

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, therapeutic allogeneic lymphocytes and cyclophosphamide in people with Kidney Cancer, run by Alliance for Clinical Trials in Oncology at 6 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: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 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?

Overall response rate (time frame: Up to 5 years). The study lists 5 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 NCT00027573, which also lists 1 linked publication.

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 14 Jul 2016.

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