Method of reducing side effects of chemotherapy in cancer patients

• US 6,462,017 B1
• Filed: 05/01/2000
• Issued: 10/08/2002
• Est. Priority Date: 05/01/2000
• Status: Expired due to Term

• Current Assignee: SciClone Pharmaceuticals International Ltd. (SciClone Pharmaceuticals (Holdings) Ltd.)
• Original Assignee: SciClone Pharmaceuticals, Inc.
• Inventors: Rudolph, Alfred R., Tam, Vincent Chung-Ying, Quan, Maggie Jie
• Primary Examiner(s): Carlson, Karen Cochrane
• Assistant Examiner(s): Robinson, Hope A.
• Application Number:
  US09/561,917
• Time in Patent Office: 890 Days
• Field of Search: 530/324, 530/326, 530/334, 435/7.1, 435/7.9, 514/274, 514/2, 514/12, 514/21, 514/772.3, 424/26, 424/78.37, 424/85.7, 528/396
• US Class Current: 514/9.7
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/513 having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 31/675 having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
• CPC Class Codes: A61K 31/704 attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin digitoxin A61K31/7048
• CPC Class Codes: A61K 31/7048 having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin , digitoxin or digoxin
• CPC Class Codes: A61K 33/24 Heavy metals; Compounds thereof
• CPC Class Codes: A61K 33/243 Platinum; Compounds thereof
• CPC Class Codes: A61K 38/2292 Thymosin; Related peptides
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/08 for nausea, cinetosis or vertigo; Antiemetics
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 39/00 General protective or antinoxious agents
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

A method for reducing the severity of chemotherapy side effects in cancer patients by administering thymosin α₁ in conjunction with the administration of a chemotherapy agent to the patient. As a result of the reduction of post-chemotherapy side effects, patients experience an increase in the quality of life.

Claims

1. A method of reducing side effects of chemotherapy in a cancer patient, said side effects being selected from the group consisting of loss of appetite, loss of sleep, fatigue, reduction in daily activity, decline in overall feeling, depression, nausea and vomiting and combinations of said side effects, comprising administering to a cancer patient thymosin α

₁ (Tα

₁), said Tα

₁ being administered prior to administration to said patient of at least one chemotherapy agent selected from the group consisting of allopurinol sodium, dolasetron mesylate, pamidronate disodium, etidronate, fluconazole, epoetin alfa, levamisole HCL, amifostine, granisetron HCL, leucovorin calcium, sargramostim, dronabinol, mesna, filgrastim, pilocarpine HCL, octreotide acetate, dexrazoxane, ondansetron HCL, ondansetron, busulfan, carboplatin, cisplatin, thiotepa, melphalan HCL, melphalan, cyclophosphamide, ifosfamide, chlorambucil, mechlorethamine HCL, carmustine, lomustine, polifeprosan 20 with carmustine implant, streptozocin, doxorubicin HCL, bleomycin sulfate, daunirubicin HCL, dactinomycin, daunorucbicin citrate, idarubicin HCL, plimycin, mitomycin, pentostatin, mitoxantrone, valrubicin, cytarabine, fludarabine phosphate, floxuridine, cladribine, methotrexate, mercaptipurine, thioguanine, capecitabine, methyltestosterone, nilutamide, testolactone, bicalutamide, flutamide, anastrozole, toremifene citrate, tamoxifen, estramustine phosphate sodium, ethinyl estradiol, estradiol, esterified estrogens, conjugated estrogens, leuprolide acetate, goserelin acetate, medroxyprogesterone acetate, megestrol acetate, levamisole HCL, aldesleukin, irinotecan HCL, dacarbazine, asparaginase, etoposide phosphate, gemcitabine HCL, trastuzumab, altretamine, topotecan HCL, hydroxyurea, interferon alfa-2b, mitotane, procarbazine HCL, vinorelbine tartrate, E. coli L-asparaginase, Erwinia L-asparaginase, vincristine sulfate, denileukin diftitox, aldesleukin, rituximab, interferon alfa-2a, paclitaxel, docetaxel, BCG live (intravesical), vinblastine sulfate, etoposide, tretinoin, teniposide, porfimer sodium, fluorouracil, betamethasone sodium phosphate and betamethasone acetate, letrozole, etoposide citrororum factor, folinic acid, calcium leucouorin, 5-fluorouricil, adriamycin, cytoxan, and diamino dichloro platinum, said chemotherapy agent in combination with thymosin α

₁ being administered in an amount effective to reduce said side effects of chemotherapy in said patient.

2. The method of claim 1 wherein said Tα

₁ also is administered subsequent to said chemotherapy agent.

3. The method of claim 1 wherein said Tα

₁ is administered on each of a plurality of days prior to said chemotherapy agent.

4. The method of claim 1 wherein a single administration of Tα

₁ is administered one day immediately prior to administration of said chemotherapy agent.

5. The method of claim 1 wherein a single administration of Tα

₁ is administered on each of two days immediately prior to administration of said chemotherapy agent.

6. The method of claim 1 wherein a single administration of Tα

₁ is administered on each of three days immediately prior to administration of said chemotherapy agent.

7. The method of claim 1 wherein a single administration of Tα

₁ is administered on each of four days immediately prior to administration of said chemotherapy agent.

8. The method of claim 1 wherein said chemotherapy agent is selected from the group consisting of etoposide citrororum factor, folinic acid, calcium leucouorin, 5-fluorouricil, adriamycin, cytoxan, diamino dichloro platinum and combinations of said chemotherapy agent.

9. The method of claim 2 wherein a single administration of Tα

₁ is administered one day immediately subsequent to administration of said chemotherapy agent.

10. The method of claim 2 wherein a single administration of Tα

₁ is administered on each of two days immediately subsequent to said administration of said chemotherapy agent.

11. The method of claim 2 wherein Tα

₁ is administered on a plurality of days prior to and subsequent to the administration of said chemotherapy agent.

12. The method of claim 2 wherein a single administration of Tα

₁ is administered one day immediately prior to and one day immediately subsequent to administration of said chemotherapy agent.

13. The method of claim 2 wherein a single administration of Tα

₁ is administered on each of two days immediately days prior to and two days immediately subsequent to the administration of said chemotherapy agent.

14. The method of claim 1 wherein Tα

₁ is administered at a dosage within a range of about 0.1-3.2 mg.

15. The method of claim 1 wherein Tα

₁ is administered at a dosage of about 1.6 mg.