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Recurrent Adult Soft Tissue SarcomaPhase 2NCT00089544

Preoperative Thalidomide With Radiation Therapy For Patients With Low-Grade Primary Soft Tissue Sarcoma or Thalidomide With Radiation Therapy and Chemotherapy For Patients With High-Grade or Intermediate-Grade Primary Soft Tissue Sarcoma of the Arm, Leg, or Body Wall

A Phase 2 study testing Dacarbazine, Doxorubicin Hydrochloride and Filgrastim in people with Recurrent Adult Soft Tissue Sarcoma and Stage I Adult Soft Tissue Sarcoma AJCC v7, run by National Cancer Institute (NCI) at 1 site 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

Thalidomide may stop the growth of soft tissue sarcoma by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as doxorubicin, ifosfamide, and dacarbazine, work in different ways to stop tumor cells from dividing so they stop growing or… Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
Dacarbazine, Doxorubicin Hydrochloride and Filgrastim
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
17 Jun 2004to 5 Nov 2013
Phase
Phase 2

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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnosis of primary soft tissue sarcoma
  • T2a or T2b disease
  • Superficial or deep tumor
  • Grade 1, 2, 3, or 4
  • Tumor located on the upper extremity (including shoulder), lower extremity (including hip), or trunk
  • Meets 1 of the following criteria:
Show all 74Show fewer
  • Tumor ? 8 cm in maximal diameter and grade 3 or 4 (intermediate or high grade) (cohort A)
  • Tumor > 5 cm in maximal diameter and grade 1 or 2 (low grade) (cohort B)
  • Locally recurrent disease allowed provided there has been no prior radiotherapy to the primary tumor
  • No histologically confirmed rhabdomyosarcoma, extraosseous Ewing's primitive neuroectodermal tumors, osteosarcoma or chondrosarcoma, Kaposi's sarcoma, angiosarcoma, desmoid tumors, or dermatofibrosarcoma protuberans
  • No overt evidence of lung metastases (CT scan evidence of small incidental lesions without histologic diagnosis allowed)
  • No evidence of other metastases
  • No sarcoma of the head, neck, intra-abdominal, or retroperitoneal region
  • Performance status - Zubrod 0-1
  • At least 2 years
  • Absolute neutrophil count ? 1,500/mm^3
  • Platelet count ? 120,000/mm^3
  • Hemoglobin ? 8.0 g/dL (cohort A)
  • No known hypercoagulable disorders, such as the following:
  • APC resistance (factor V Leiden)
  • Protein S deficiency
  • Protein C deficiency
  • Antithrombin III deficiency
  • Hyperhomocystinemia
  • Dysplasminogenemia
  • High plasminogen activator inhibitor
  • Dysfibrinogenemia
  • Antiphospholipid syndrome
  • Thrombocythemia
  • Dysproteinemia
  • Fibrin split products < 2 times upper limit of normal (ULN)
  • Fibrinogen > 200 mg/dL
  • Bilirubin ? 1.5 mg/dL (1.0 mg/dL for patients with Gilbert's syndrome)
  • AST and ALT ? 2.0 times ULN
  • PT and PTT < 1.25 times ULN (except in patients treated with anticoagulants for unrelated medical conditions [e.g., atrial fibrillation])
  • No history of hepatic cirrhosis
  • Creatinine ? 1.5 mg/dL
  • Creatinine clearance > 60 mL/min
  • No atherosclerotic coronary artery disease that required bypass surgery within the past year
  • No uncompensated coronary artery disease by ECG or physical examination
  • No myocardial infarction within the past 6 months
  • No severe or unstable angina within the past 6 months
  • No uncompensated congestive heart failure
  • No New York Heart Association class II-IV heart disease
  • No symptomatic peripheral vascular disease
  • No history of deep vein thrombosis
  • Cohort A only:
  • EF ? 50% within the past 6 months
  • LVEF > 50%
  • No pulmonary embolus except if caused directly by foreign body implants (e.g., central venous catheters or portacaths)
  • No global neurocognitive symptomatology
  • No fatigue ? grade 2
  • No history of uncontrolled seizures or uncontrolled seizure disorder
  • No sensory neuropathy ? grade 2 except for localized neuropathy due to mechanical cause or trauma
  • No other malignancies within the past 3 years except non-invasive malignancies (e.g., carcinoma in situ of the cervix, breast, or oral cavity) or squamous or basal cell skin cancer
  • No history of uncontrolled myxedema
  • No hypothyroidism ? grade 3
  • No active uncontrolled bacterial, viral, or fungal infection
  • No other significant illness that would preclude surgery
  • No other major illness or psychiatric impairment that would preclude study therapy
  • No known AIDS
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 effective barrier methods of contraception for 4 weeks before, during, and for at least 4 weeks after study treatment
  • No prior thalidomide
  • No prior biologic therapy for this tumor
  • No prior chemotherapy for this tumor
  • See Disease Characteristics
  • No prior radiotherapy for this tumor
  • See Cardiovascular
  • No other concurrent investigational drugs
  • No concurrent sedating drugs
  • No concurrent illegal sedating "recreational" drugs
  • No concurrent alcohol intake of more than 1 drink per day

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Radiation Therapy Oncology Group

    Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

Official title: A Pilot Phase II Study of Pre-Operative Radiation Therapy and Thalidomide (IND 48832; NSC 66847) for Low Grade Primary Soft Tissue Sarcoma or Pre-Operative MAID/Thalidomide/Radiation Therapy for High/Intermediate Grade Primary Soft Tissue Sarcoma of the Extremity or Body Wall

Thalidomide may stop the growth of soft tissue sarcoma by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as doxorubicin, ifosfamide, and dacarbazine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving thalidomide together with radiation therapy and/or chemotherapy before surgery may shrink the tumor so that it can be removed. This phase II trial is studying how well giving preoperative (before surgery) thalidomide together with radiation therapy works in treating patients with low-grade primary soft tissue sarcoma, and how well giving thalidomide together with radiation therapy, doxorubicin, ifosfamide, and dacarbazine works in treating patients with high-grade or intermediate-grade primary soft tissue sarcoma of the arm, leg, chest wall, or abdominal wall.

Read the detailed description

OBJECTIVES:

  1. Determine the treatment delivery and toxicity of the combination of thalidomide and radiotherapy in patients with low-grade primary soft tissue sarcoma of the extremity or body wall.

II. Determine the treatment delivery and toxicity of the combination of thalidomide and doxorubicin, ifosfamide, dacarbazine, and radiotherapy in patients with high- or intermediate-grade primary soft tissue sarcoma of the extremity or body wall and compare these results with those of patients treated on RTOG-9514.

III. Determine the feasibility of using specific tissue and circulating biomarkers of antiangiogenic response in patients treated with these regimens, in a multi-institutional setting.

IV. Determine the quantitative changes and patient variabilities of these biomarkers before, during, and after therapy with these regimens.

  1. Determine the baseline data sets of biomarkers, particularly circulating endothelial cells, in patients treated with these regimens.

VI. Determine the tolerance to long-term post-operative thalidomide in these patients.

VII. Determine the clinical response to pre-operative therapy in these patients.

VIII. Correlate local control and disease-free survival with surrogate biological endpoints in patients treated with these regimens.

OUTLINE: This is a pilot, cohort study. Patients with high- or intermediate-grade tumors >= 8 cm in diameter are assigned to cohort A and patients with low-grade tumors > 5 cm in diameter are assigned to cohort B.

Cohort A: Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive filgrastim (G-CSF) subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 26-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.

Cohort B: Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 44 patients (22 per cohort) will be accrued for this study within 17 months.

Being tested
Dacarbazine, Doxorubicin Hydrochloride, Filgrastim, Ifosfamide, Laboratory Biomarker Analysis
Medical subject headings
Sarcoma

What participants receive

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

  • DacarbazineDrug

    Also called 4-(Dimethyltriazeno)imidazole-5-carboxamide, 5-(Dimethyltriazeno)imidazole-4-carboxamide, Asercit, Biocarbazine

    Given IV

  • Doxorubicin HydrochlorideDrug

    Also called 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin

    Given IV

  • FilgrastimBiological

    Also called FILGRASTIM, LICENSE HOLDER UNSPECIFIED, G-CSF, Neupogen, r-metHuG-CSF

    Given subcutaneously

  • IfosfamideDrug

    Also called Asta Z 4942, Asta Z-4942, Cyfos, Holoxan

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Irradiate, Irradiated, irradiation

    Undergo radiotherapy

  • ThalidomideDrug

    Also called (+)-Thalidomide, (-)-Thalidomide, .alpha.-Phthalimidoglutarimide, 2, 6-Dioxo-3-phthalimidopiperidine

    Given orally

  • Therapeutic Conventional SurgeryProcedure or surgery

    Undergo surgical resection

Study groups in NCT00089544
Study groupRoleWhat they receive
Cohort A (chemotherapy, radiation, thalidomide, surgery)ExperimentalPatients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 26-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
Receives: Drug: Dacarbazine; Drug: Doxorubicin Hydrochloride; Biological: Filgrastim; Drug: Ifosfamide; Other: Laboratory Biomarker Analysis; Radiation: Radiation Therapy; Drug: Thalidomide; Procedure: Therapeutic Conventional Surgery
Cohort B (thalidomide, radiation, surgery)ExperimentalPatients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
Receives: Other: Laboratory Biomarker Analysis; Radiation: Radiation Therapy; Drug: Thalidomide; Procedure: Therapeutic Conventional Surgery

What is being measured

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

  1. Treatment Delivery With Compliance Defined as Receiving at Least 95% of the Pre-operative Protocol Dose of RT, All 3 Cycles of MAID (if Applicable), and Receive Thalidomide on 75% of the Days During Radiation

    Was to be estimated using a binomial distribution and accompanied by the associated 95% confidence interval. Due to early study closure, this endpoint could not be fully evaluated per the protocol plan.

    Measured: Duration of treatment (which can continue up to approximately 15 months).

Secondary outcomes (2)

  1. Wound Complication (Grades 2, 3, 4, and 5) as Measured by CTCAE v3.0

    Will be estimated using a binomial distribution and accompanied by the associated 95% confidence interval.

    Measured: From start of treatment to time of surgery

  2. Response to Pre-operative Therapy Assessed Using RECIST Criteria

    Measured: From start of treatment to time of surgery.

Timeline

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

  1. First posted9 Aug 2004 (estimated)
  2. Study start17 Jun 2004
  3. Primary completion27 Sep 2011
  4. Study completion5 Nov 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00089544
Sponsor's protocol ID
NCI-2012-02588
Other IDs
NCI-2012-02588, RTOG-0330, CDR0000365499, RTOG-0330, RTOG-0330, U10CA021661
Status last verified
Mar 2018
First submitted
6 Aug 2004
Last updated
13 Apr 2018

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