AzTrials
AzTrials

Bladder CancerPhase 2NCT00003657

High-dose ICE With Amifostine

A Phase 2 study testing filgrastim, Amifostine and Carboplatin in people with Bladder Cancer and Brain and Central Nervous System Tumors, run by Dana-Farber Cancer Institute at 3 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The purpose of the study is to evaluate the combination of amifostine and high dose chemotherapy with blood stem cell support. Amifostine is a druf developed to protect normal tissues against the toxicities of chemotherapy and radiotherapy and has reduced the side effects of chemotherapy given at conventional doses. Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
filgrastim, Amifostine and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
3 sitesUnited States
Study dates
Jul 1998to Jun 2002
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 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Eligibility Criteria:

  • Histologically documented malignancy
  • Metastatic or locally unresectable malignancy
  • Patient may be responding to therapy
  • Responding Stage IIIC/IV or recurrent/refractory ovarian carcinoma (ineligible for other bone marrow or stem cell transplant protocols)
  • Relapsed germ cell carcinomas
  • Relapsed lymphomas (ineligible for other BMT or SCT protocols
  • SCLC in PR or CR
  • Sarcomas in or near complete remission after induction chemotherapy
  • Stage IIIB NSCLC responding to chemotherapy
  • Responsive bladder, head and neck carcinoma, or carcinoma of unknown primary
  • Other tumors without curative or first line therapy (not eligible for phase II or III studies)
  • Aged 18 to 55 Physiologic years -- Performance status: PS 0-1
  • Prior Treatment
  • > 1 week since surgery or RT
  • > 3 weeks since prior CT
  • Informed Consent
  • Required initial laboratory data:
  • White Cell Count Life ≥ 3000/ul
  • Platelet Count ≥ 100,000/ul
  • Creatinine ≤ 1.5 x normal
  • Bilirubin ≤ 1.5 x normal
  • No current metastases
  • BM Asp \& Bx
  • Brain CAT
  • Creatinine Clearance ≥ 60 cc/min
  • SGOT < 2.5 x normal
  • No other serious medical or psychiatric illness which would prevent informed consent or general anesthesia
  • Uncontrolled or severe cardiovascular disease including recent (< 6 months) myocardial infarction, or congestive heart failure
  • Active uncontrolled bacterial, viral, or fungal infection; or an active duodenal ulcer; until these conditions are corrected or controlled
  • Pregnancy
  • Unable to stop taking antihypertensive medication 24 hours prior to administration of Ethyol

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: High Dose Ifosfamide, Carboplatin and Etoposide With Amifostine Chemoprotection

The purpose of the study is to evaluate the combination of amifostine and high dose chemotherapy with blood stem cell support. Amifostine is a druf developed to protect normal tissues against the toxicities of chemotherapy and radiotherapy and has reduced the side effects of chemotherapy given at conventional doses.

Being tested
filgrastim, Amifostine, Carboplatin, Etoposide, Ifosfamide
Keywords
metastatic osteosarcoma, recurrent non-small cell lung cancer, chondrosarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, recurrent osteosarcoma, stage III bladder cancer, recurrent bladder cancer, stage IV bladder cancer, stage III malignant testicular germ cell tumor, recurrent malignant testicular germ cell tumor, stage IIIB non-small cell lung cancer, unspecified adult solid tumor, protocol specific, classic Kaposi sarcoma, immunosuppressive treatment related Kaposi sarcoma
Medical subject headings
Urinary Bladder Neoplasms, Central Nervous System Neoplasms, Neoplasms, Unknown Primary, Head and Neck Neoplasms, Kidney Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Sarcoma

What participants receive

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

Study groups in NCT00003657
Study groupRoleWhat they receive
High Dose ICF with AmifostineExperimental* Patients undergo peripheral blood stem cell transplantation (PBSC) harvest on day -8, * ifosfamide IV, carboplatin IV etoposide IV (ICE) by 96 hour continuous infusion on days -7 to -4. * Patients receive amifostine IV twice a day on days -7 to -3. * PBSCs are reinfused on day 0. * Filgrastim (G-CSF) is administered subcutaneously beginning on day 0 at least 2 hours after infusion of the stem cells and continuing until blood cell counts recover. * Patients are followed monthly for the first 2 months and then for survival.
Receives: Biological: filgrastim; Drug: Amifostine; Drug: Carboplatin; Drug: Etoposide; Drug: Ifosfamide; Procedure: peripheral blood stem cell transplantation

What is being measured

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

  1. Percentage of Participants with Grade 2 or higher renal toxicities

    Measured: 2 Months

Secondary outcomes (1)

  1. Full Pharmacokinetic profiles for ifosfamide and its metabolites MTD of ICE with amifostine

    Measured: 2 Months

Timeline

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

  1. First posted31 Mar 2004 (estimated)
  2. Study startJul 1998
  3. Primary completionNov 2000
  4. Study completionJun 2002

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003657
Sponsor's protocol ID
98-068
Other IDs
P30CA006516, DFCI-98068, ALZA-97-038-ii, NCI-V98-1491
Status last verified
Jan 2017
First submitted
1 Nov 1999
Last updated
20 Jan 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Elias AD, Richardson P, Tretyakov O, et al.: Amifostine with high dose infosfamide, carboplatin, and etoposide (ICE) with hematopoietic STEM cell support. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A197, 2000.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, Amifostine and Carboplatin in people with Bladder Cancer and Brain and Central Nervous System Tumors, run by Dana-Farber Cancer Institute at 3 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 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Percentage of Participants with Grade 2 or higher renal toxicities (time frame: 2 Months). 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 NCT00003657, 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 20 Jan 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in